Drug Information
View drug alerts Information in New York
The Drug Information Center has a wealth of information to help you understand how drugs
impact your health as well as their place in today's healthcare environment.
The information you'll find in the center covers a number of important topics ranging from
drug safety and side effects to medication costs and errors. You'll also notice from
time to time we will display drug alerts. These alerts will let you know when a New Drug
is put on the market, if a drug has been recalled, and if a drug has a new indication or
use.
Drug Name | Drug Reason | Date |
---|---|---|
Aurobindo
Aurobindo announced a voluntary recall
of 80 lots of amlodipine/valsartan tablets,
valsartan/hydrochlorothiazide tablets, and valsartan
tablets due to an impurity. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/Safety/Recalls/ucm629213.htm Source:
FDA website
|
Drug Recall | 01-02-19 |
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding
its voluntary recall to include 8 additional lots of
losartan potassium tablets due to detection of trace
amounts of impurity in the active pharmaceutical
ingredient. Contact your healthcare provider with
questions. More details may be viewed
at:https://www.fda.gov/Safety/Recalls/ucm629261.htm
Source: FDA website
|
Drug Recall | 01-04-19 |
Fluzone Quadrivalent
The Food and Drug Administration (FDA)
approved Fluzone® Quadrivalent (influenza vaccine
0.5 mL injection) to include influenza vaccination of
children age 6 through 35 months. Source: FDA website
|
New Indication | 01-24-19 |
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding
its voluntary recall to include 6 lots of losartan
potassium/hydrochlorothiazide tablets due to detection
of trace amounts of impurity in the active
pharmaceutical ingredient. Contact your healthcare
provider with any questions. More details may be viewed
at: https://www.fda.gov/Safety/Recalls/ucm629693.htm
Source: FDA website
|
Drug Recall | 01-22-19 |
Prinston Pharmaceutical
Prinston Pharmaceutical announced a
voluntary recall of irbesartan and
irbesartan/hydrochlorothiazide tablets due to detection
of trace amounts of impurity in the active
pharmaceutical ingredient. Contact your healthcare
provider with any questions. More details may be viewed
at: https://www.fda.gov/Safety/Recalls/ucm629627.htm
Source: FDA website
|
Drug Recall | 01-18-19 |
Evekeo ODT
The Food and Drug Administration (FDA)
approved Evekeo ODT™ (amphetamine sulfate orally
disintegrating tablets) for the treatment of attention
deficit hyperactivity disorder (ADHD) in pediatric
individuals 6 to 17 years of age. Source: FDA website
|
New Formulation | 01-30-19 |
Gloperba
The Food and Drug Administration (FDA)
approved Gloperba® (colchicine oral solution) for
the prevention of gout flares in adults. Source: FDA
website
|
New Formulation | 01-30-19 |
Jeuveau
The Food and Drug Administration (FDA)
approved Jeuveau™ (prabotulinumtoxinA-xvfs
injection) for the temporary improvement in the
appearance of moderate to severe glabellar lines
associated with corrugator and/or procerus muscle
activity in adults. Source: FDA website
|
New Formulation | 02-01-19 |
Cablivi
The Food and Drug Administration (FDA)
approved Cablivi® (caplacizumab-yhdp injection) for
the treatment of adults with acquired thrombotic
thrombocytopenic purpura (aTTP). Source: FDA website
|
New Drug | 02-06-19 |
Levetiracetam
Dr. Reddy's Laboratories announced a
voluntary recall of levetiracetam in 0.54% sodium
chloride injection 1500 mg/100 mL due to mislabeling.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/Safety/Recalls/ucm630542.htm Source:
FDA website
|
Drug Recall | 02-04-19 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) as
adjuvant therapy in the treatment of individuals with
resected, high-risk stage III melanoma. Source: FDA
website
|
New Indication | 02-15-19 |
Kisqali Femara Co-Pack
The Food and Drug Administration (FDA)
approved Kisqali® Femara® Co-Pack
(ribociclib/letrozole tablets) as initial
endocrine-based therapy for the treatment of
pre/perimenopausal or postmenopausal women with hormone
receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic breast
cancer. Source: FDA website
|
New Indication | 02-13-19 |
Vancomycin
The Food and Drug Administration (FDA)
approved premixed Vancomycin injection in a ready-to-use
bag approved in adults and pediatric individuals (1
month and older) for the treatment of septicemia,
infective endocarditis, skin and skin structure
infections, bone infections, and lower respiratory tract
infections. Source: FDA website
|
New Formulation | 02-15-19 |
Egaten
The Food and Drug Administration (FDA)
approved Egaten™ (triclabendazole tablets) for the
treatment of fascioliasis
in individuals 6 years of age and older. Source: FDA
website
|
New Drug | 02-13-19 |
Esperoct
The Food and Drug Administration (FDA)
approved Esperoct® (turoctocog alfa pegol injection)
for adults and children with hemophilia A for routine
prophylaxis to reduce the frequency of bleeding
episodes, on-demand treatment and control of bleeding
episodes and perioperative management of bleeding,
Source: FDA website
|
New Drug | 02-19-19 |
Uloric
The Food and Drug Administration (FDA)
concluded there is an increased risk of death with
Uloric (febuxostat) compared with another gout
medication, allopurinol. This conclusion is based on the
review of results from a safety trial that found an
increased risk of heart-related death and death from all
causes with Uloric. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM631824
Source: FDA website
|
Drug Warning | 02-21-19 |
Lonsurf
The Food and Drug Administration (FDA)
approved Lonsurf® (trifluridine/tipiracil tablets)
for the treatment of adults with metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma
previously treated with at least 2 prior lines of
chemotherapy that included a fluoropyrimidine, a
platinum, either a taxane or irinotecan, and if
appropriate, HER2/neu-targeted therapy. Source: FDA
website
|
New Indication | 02-25-19 |
Soliqua
The Food and Drug Administration (FDA)
approved Soliqua® (insulin glargine/lixisenatide
injection) for use as an add-on to diet and exercise in
adults with type 2 diabetes who are uncontrolled on oral
antidiabetic medications. Source: FDA website
|
Expanded Indication | 02-25-19 |
Lotemax SM
The Food and Drug Administration (FDA)
approved Lotemax®; SM (loteprednol etabonate
ophthalmic gel) for the treatment of postoperative
inflammation and pain following ocular surgery. Source:
FDA website
|
New Formulation | 02-25-19 |
Herceptin Hylecta
The Food and Drug Administration (FDA)
approved Herceptin Hylecta™
(trastuzumab/hyaluronidase subcutaneous injection) for
the treatment of human epidermal growth factor receptor
2 (HER2) overexpressing breast cancer. Source: FDA
website
|
New Formulation | 02-28-19 |
Adhansia XR
The Food and Drug Administration (FDA)
approved Adhansia XR™ (methylphenidate
extended-release capsules) for the treatment of
attention deficit hyperactivity disorder (ADHD) in
individuals 6 years and older. Source: FDA website
|
New Formulation | 02-27-19 |
Xeljanz/Xeljanz XR
The Food and Drug Administration (FDA)
alerted the public that a safety clinical trial found an
increased risk of blood clots in the lungs and death
when a 10 mg twice daily dose of Xeljanz®
(tofacitinib tablets) or Xeljanz XR® (tofacitinib
extended-release tablets) was used in individuals with
rheumatoid arthritis (RA). This dose is only approved
for ulcerative colitis (UC). Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm
Source: FDA website
|
Drug Warning | 02-25-19 |
Drospirenone/ethinyl estradiol
Apotex Corp announced a voluntary
recall of 4 lots of drospirenone/ethinyl estradiol
tablets for contraception due to the possibility of
missing/incorrect tablet arrangement. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/Safety/Recalls/ucm632629.htm Source:
FDA website
|
Drug Recall | 03-04-19 |
AurobindoPharma
AurobindoPharma announced an expansion
of its voluntary recall to include 38 additional lots of
valsartan and amlodipine/valsartan tablets due to
unacceptable amounts of an impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/Safety/Recalls/ucm632442.htm Source:
FDA website
|
Drug Recall | 03-01-19 |
AvKARE
AvKare announced a voluntary recall of
one lot of sildenafil 100 mg tablets and one lot of
trazodone 100 mg tablets due to a product mix-up of the
listed two separate products inadvertently packaged
together during bottling. Contact your health care
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-issues-voluntary-nationwide-recall-sildenafil-100mg-tablets-and-trazodone-100mg-tablets-due
Source: FDA website
|
Drug Recall | 12-09-20 |
Macleods Pharmaceuticals
Macleods Pharmaceuticals Limited
announced a voluntary recall of one lot of losartan
potassium/hydrochlorothiazide tablets due to trace
amounts of an unexpected impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/Safety/Recalls/ucm631880.htm Source:
FDA website
|
Drug Recall | 02-25-19 |
Camber Pharmaceuticals
Camber Pharmaceuticals announced a
voluntary recall of 87 lots of valsartan tablets due to
trace amounts of an unexpected impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/Safety/Recalls/ucm632395.htm Source:
FDA website
|
Drug Recall | 02-28-19 |
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced a
voluntary recall of 60 lots of losartan tablets and 54
lots of losartan/hydrochlorothiazide tablets due to
trace amounts of an unexpected impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/Safety/Recalls/ucm632509.htm Source:
FDA website
|
Drug Recall | 03-03-19 |
Myobloc
The Food and Drug Administration (FDA)
approved Myobloc® (rimabotulinumtoxinB injection)
for the treatment of adults with chronic sialorrhea.
Source: FDA website
|
New Indication | 09-03-19 |
Ofev
The Food and Drug Administration (FDA)
approved Ofev® (nintedanib capsules) to slow the
rate of decline in pulmonary function in adults with
interstitial lung disease associated with systemic
sclerosis or scleroderma. Source: FDA website
|
New Indication | 09-06-19 |
Tybost
The Food and Drug Administration (FDA)
approved Tybost® (cobicistat tablets) for use with
atazanavir and other antiretroviral agents in the
treatment of human immunodeficiency virus-1 (HIV-1)
infection in pediatric individuals weighing 35 kg or
more. Source: FDA website
|
Expanded Indication | 08-22-19 |
Sovaldi
The Food and Drug Administration (FDA)
approved Sovaldi® (sofosbuvir tablets) for pediatric
individuals 3 years of age and older with genotype 2 or
3 chronic hepatitis C virus (HCV) infection without
cirrhosis or with compensated cirrhosis in combination
with ribavirin. Source: FDA website
|
Expanded Indication | 08-28-19 |
Harvoni
The Food and Drug Administration (FDA)
approved Harvoni® (sofosbuvir/ledipasvir tablets)
for pediatric individuals 3 years of age and older with
genotype 2 or 3 chronic hepatitis C virus (HCV)
infection without cirrhosis or with compensated
cirrhosis in combination with ribavirin. Source: FDA
website
|
Expanded Indication | 08-28-19 |
Riomet ER
The Food and Drug Administration (FDA)
approved Riomet ER™ (metformin extended-release
oral suspension) as an adjunct to diet and exercise to
improve glycemic control in adults and pediatric
individuals 10 years of age and older with type 2
diabetes mellitus. Source: FDA website
|
New Formulation | 08-29-19 |
Pacifico National
Pacifico National, doing business as
AmEx Pharmacy, announced a voluntary recall of all lots
of Bevacizumab injection due to quality and safety
concerns. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab
Source: FDA website
|
Drug Recall | 08-30-19 |
Hospira
Hospira announced a voluntary recall
of one lot of Bacteriostatic water for injection due to
lack of confirmation of sterilization for some vials.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bacteriostatic-water-injection-usp-due
Source: FDA website
|
Drug Recall | 09-06-19 |
Aczone
The Food and Drug Administration (FDA)
approved Aczone® (dapsone topical gel) for treatment
of acne vulgaris in individuals aged 9 years and older.
Source: FDA website
|
Expanded Indication | 09-12-19 |
Nucala
The Food and Drug Administration (FDA)
approved Nucala® (mepolizumab injection) for use in
children as young as 6 years of age who have severe
eosinophilic asthma. Source: FDA website
|
Expanded Indication | 09-12-19 |
Gvoke
The Food and Drug Administration (FDA)
approved Gvoke (glucagon injection) for the treatment of
severe hypoglycemia in children and adults aged two
years and older with diabetes. Source: FDA website
|
New Formulation | 09-10-19 |
Ibsrela
The Food and Drug Administration (FDA)
approved Ibsrela® (tenapanor tablets) for the
treatment of irritable bowel syndrome with constipation
in adults. Source: FDA website
|
New Drug | 09-12-19 |
KRS Global Biotechnology
KRS Global Biotechnology announced a
voluntary recall of all lots of unexpired drugs intended
to be sterile due to lack of assurance of sterility.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/krs-global-biotechnology-inc-issues-voluntary-nationwide-recall-all-human-and-animal-sterile-drug
Source: FDA website
|
Drug Recall | 09-13-19 |
Natpara
Takeda announced a recall for all
doses of Natpara injection due to a potential issue
related to rubber particulates originating from the
Natpara cartridge. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/takeda-issues-us-recall-natparar-parathyroid-hormone-injection-due-potential-rubber-particulate
Source: FDA website
|
Drug Recall | 09-05-19 |
Ibrance, Kisqali, Verzenio
The Food and Drug Administration (FDA)
issued a warning that Ibrance® (palbociclib),
Kisqali® (ribociclib), and Verzenio®
(abemaciclib), used to treat advanced breast cancers,
may cause rare but severe inflammation of the lungs.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/ibrance-palbociclib-kisqali-ribociclib-and-verzenio-abemaciclib-drug-safety-communication-due-rare
Source: FDA website
|
Drug Warning | 09-13-19 |
Zantac
The Food and Drug Administration (FDA)
has reported that some prescription and over-the-counter
(OTC) Zantac® (ranitidine oral) medications used for
heartburn may contain a nitrosamine impurity. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines
Source: FDA website
|
Drug Warning | 09-13-19 |
Teflaro
The Food and Drug Administration (FDA)
approved Teflaro® (ceftaroline fosamil injection)
for the treatment of acute bacterial skin and skin
structure infections (ABSSSI) in pediatric individuals
less than 2 months of age. Source: FDA website
|
Expanded Indication | 09-17-19 |
Erleada
The Food and Drug Administration (FDA)
approved Erleada® (apalutamide tablets) for the
treatment of individuals with metastatic
castration-sensitive prostate cancer (mCSPC). Source:
FDA website
|
Expanded Indication | 09-18-19 |
Delstrigo
The Food and Drug Administration (FDA)
approved Delstrigo™
(doravirine/lamivudine/tenofovir disoproxil fumarate
tablets), as a complete regimen, to include adults with
human immunodeficiency virus (HIV)-1 infection who are
virologically suppressed (HIV-1 RNA less than 50 copies
per mL) on a stable antiretroviral regimen with no
history of treatment failure and no known substitutions
associated with resistance to Pifeltro (doravirine) or
the individual components of Delstrigo
(doravirine/lamivudine/tenofovir disoproxil fumarate).
Source: FDA website
|
Expanded Indication | 09-20-19 |
Pifeltro
The Food and Drug Administration (FDA)
approved Pifeltro™ (doravirine tablets), in
combination with other antiretroviral agents, to include
adults with human immunodeficiency virus (HIV)-1
infection who are virologically suppressed (HIV-1 RNA
less than 50 copies per mL) on a stable antiretroviral
regimen with no history of treatment failure and no
known substitutions associated with resistance to
Pifeltro (doravirine) or the individual components of
Delstrigo (doravirine/lamivudine/tenofovir disoproxil
fumarate). Source: FDA website
|
Expanded Indication | 09-20-19 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) in
combination with Lenvima® (lenvatinib capsules) for
the treatment of individuals with advanced endometrial
carcinoma that is not microsatellite instability high
(MSI-H) or mismatch repair deficient (dMMR) and who have
disease progression following prior systemic therapy but
are not candidates for curative surgery or radiation.
Source: FDA website
|
New Indication | 09-17-19 |
Ozobax
The Food and Drug Administration (FDA)
approved Ozobax™ (baclofen oral solution) for the
treatment of spasticity resulting from multiple
sclerosis. It may also have value in individuals with
spinal cord injuries or diseases. Source: FDA website
|
New Formulation | 09-18-19 |
Rybelsus
The Food and Drug Administration (FDA)
approved Rybelsus® (semaglutide tablets) to control
blood sugar in adults with type 2 diabetes along with
diet and exercise. Source: FDA website
|
New Formulation | 09-20-19 |
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced an
expansion of its voluntary recall to include 5
additional lots of losartan potassium tablets due to
unacceptable amounts of an impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0
Source: FDA website
|
Drug Recall | 09-20-19 |
Entresto
The Food and Drug Administration (FDA)
approved Entresto® (sacubitril/valsartan tablets)
for the treatment of symptomatic heart failure with
systemic left ventricular systolic dysfunction in
pediatric individuals aged 1 year and older. Source: FDA
website
|
Expanded Indication | 10-02-19 |
Tybost
The Food and Drug Administration (FDA)
approved Tybost® (cobicistat tablets) for
coadministration with darunavir in pediatric individuals
with human immunodeficiency virus-1 (HIV-1) infection
weighing at least 40 kg. Source: FDA website
|
Expanded Indication | 10-04-19 |
Descovy
The Food and Drug Administration (FDA)
approved Descovy® (emtricitabine/tenofovir
alafenamide tablets) in at-risk adults and adolescents
weighing at least 35 kg for human immunodeficiency
virus-1 (HIV-1) pre-exposure prophylaxis (PrEP) to
reduce the risk of HIV-1 infection from sex, excluding
those who have receptive vaginal sex. Source: FDA
website
|
New Indication | 10-03-19 |
Wilate
The Food and Drug Administration (FDA)
approved Wilate® (von Willebrand Factor/coagulation
Factor VIII complex, human injection) for treatment of
adults and adolescents with hemophilia A for routine
prophylaxis to reduce the frequency of bleeding episodes
and on demand treatment and control of bleeding
episodes. Source: FDA website
|
New Indication | 10-08-19 |
Fasenra Pen
The Food and Drug Administration (FDA)
approved Fasenra® Pen (benralizumab pre-fillled,
single-use, auto-injector) for self-administration as
add-on maintenance treatment for severe eosinophilic
asthma. Source: FDA website
|
New Formulation | 10-04-19 |
Hemady
The Food and Drug Administration (FDA)
approved Hemady™ (dexamethasone tablets) for use
in combination with other anti-myeloma products for the
treatment of adults with multiple myeloma. Source: FDA
website
|
New Formulation | 10-03-19 |
Bortezomib
The Food and Drug Administration (FDA)
approved Bortezomib injection for the treatment of
adults with multiple myeloma and for the treatment of
adults with mantle cell lymphoma who have received at
least one prior therapy. Source: FDA website
|
New Formulation | 10-04-19 |
Quzyttir
The Food and Drug Administration (FDA)
approved Quzyttir™ (cetirizine injection) for the
treatment of acute urticaria in adults and children 6
months of age and older. Source: FDA website
|
New Formulation | 10-04-19 |
Bonsity
The Food and Drug Administration (FDA)
approved Bonsity (teriparatide subcutaneous injection)
as a follow-on product for Forteo® (teriparatide
subcutaneous injection) for the treatment of
osteoporosis in individuals at high risk for fractures.
Source: FDA website
|
New Formulation | 10-04-19 |
Scenesse
The Food and Drug Administration (FDA)
approved Scenesse® (afamelanotide subcutaneous
implant) to increase pain-free light exposure in adults
with a history of phototoxic reactions (damage to skin)
from erythropoietic protoporphyria. Source: FDA website
|
New Drug | 10-08-19 |
Aklief
The Food and Drug Administration (FDA)
approved Aklief® (trifarotene cream) for the
treatment of acne vulgaris in individuals 9 and older.
Source: FDA website
|
New Drug | 10-04-19 |
Beovu
The Food and Drug Administration (FDA)
approved Beovu® (brolocizumab injection) for the
treatment of individuals with wet age-related macular
degeneration (AMD). Source: FDA website
|
New Drug | 10-08-19 |
Innoveix Pharmaceuticals
Innoveix Pharmaceuticals announced a
voluntary recall of all sterile compounded drug
products, within expiry, to the consumer level due to a
lack of assurance of sterility. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack
Source: FDA website
|
Drug Recall | 10-11-19 |
Lung injury update
The Food and Drug Administration (FDA)
warns the public to stop using tetrahydrocannabinol
(THC)-containing vaping products and any vaping products
obtained off the street due to reports of lung injuries.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/lung-injury-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping-products
Source: FDA website
|
Drug Warning | 10-04-19 |
Xarelto
The Food and Drug Administration (FDA)
approved Xarelto® (rivaroxaban tablets) to help
prevent blood clots for acutely ill individuals without
a high risk of bleeding during and after
hospitalization. Source: FDA website
|
Expanded Indication | 10-14-19 |
Xofluza
The Food and Drug Administration (FDA)
approved Xofluza™ (baloxavir marboxil tablets) for
the treatment of acute, uncomplicated influenza, or flu,
in people 12 years of age and older who have been
symptomatic for no more than 48 hours and who are at
high risk of developing flu-related complications.
Source: FDA website
|
Expanded Indication | 10-16-19 |
Nplate
The Food and Drug Administration (FDA)
approved Nplate® (romiplostim injection) to expand
treatment to newly diagnosed adults with immune
thrombocytopenia who have had an insufficient response
to corticosteroids, immunoglobulins or splenectomy.
Source: FDA website
|
Expanded Indication | 10-17-19 |
Secuado
The Food and Drug Administration (FDA)
approved Secuado® (asenapine transdermal system) for
the treatment of adults with schizophrenia. Source: FDA
website
|
New Formulation | 10-11-19 |
Reyvow
The Food and Drug Administration (FDA)
approved Reyvow™ (lasmiditan tablets) for the
acute treatment of migraine with or without aura in
adults. Source: FDA website
|
New Drug | 10-11-19 |
Viatrexx Bio
Viatrexx Bio announced a voluntary
recall of 10 mL sterile injectable vials of products due
to a lack of sterility assurance. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viatrexx-bio-incorporated-issues-voluntary-nationwide-recall-sterile-injectables-due-lack-sterility
Source: FDA website
|
Drug Recall | 10-15-19 |
Humate-P
CSL Behring is alerting consumers to
an error during Humate-P® (antihemophilic factor/von
Willebrand factor complex injection) packaging, the
potency data was shifted downwards and this may lead to
confusion. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/important-drug-information-humate-p-antihemophilic-factorvon-willebrand-factor-complex-human?utm_campaign=Untitled%20Email&utm_medium=email&utm_source=Eloqua
Source: FDA website
|
Drug Warning | 10-16-19 |
Ultomiris
The Food and Drug Administration (FDA)
approved Ultomiris® (ravulizumab injection) for the
treatment of atypical hemolytic uremic syndrome (aHUS)
to inhibit complement-mediated thrombotic
microangiopathy (TMA) in adults and pediatric
individuals aged one month and older. Source: FDA
website
|
New Indication | 10-20-19 |
Stelara
The Food and Drug Administration (FDA)
approved Stelara® (ustekinumab injection) for the
treatment of adults with moderately to severely active
ulcerative colitis. Source: FDA website
|
New Indication | 10-21-19 |
Botox
The Food and Drug Administration (FDA)
approved Botox® (onabotulinumtoxina injection) for
the treatment of lower limb spasticity in pediatric
individuals 2 to 17 years of age, excluding spasticity
caused by cerebral palsy. Source: FDA website
|
New Indication | 10-18-19 |
Baxdela
The Food and Drug Administration (FDA)
approved Baxdela® (delafloxacin injection and
tablets) for the treatment of adults with
community-acquired bacterial pneumonia (CABP) caused by
designated susceptible bacteria. Source: FDA website
|
New Indication | 10-24-19 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) to reduce
the risk of hospitalization for heart failure in
individuals with type 2 diabetes and established
cardiovascular (CV) disease or multiple CV risk factors.
Source: FDA website
|
Expanded Indication | 10-21-19 |
Xigduo XR
The Food and Drug Administration (FDA)
approved Xigduo® XR (dapagliflozin/metformin
extended-release tablets) to reduce the risk of
hospitalization for heart failure in individuals with
type 2 diabetes and established cardiovascular (CV)
disease or multiple CV risk factors. Source: FDA website
|
Expanded Indication | 10-21-19 |
Fiasp
The Food and Drug Administration (FDA)
approved Fiasp® (insulin aspart injection) to
include use in insulin infusion pumps for the
improvement of glycemic control in adults with type 1 or
type 2 diabetes. Source: FDA website
|
Expanded Indication | 10-22-19 |
Zejula
The Food and Drug Administration (FDA)
approved Zejula® (niraparib capsules) for the
treatment of advanced ovarian, fallopian tube, or
primary peritoneal cancer patients, who have been
treated with three or more prior chemotherapy regimens
and whose cancer is associated with homologous
recombination deficiency (HRD) positive status. Source:
FDA website
|
Expanded Indication | 10-23-19 |
Amzeeq
The Food and Drug Administration (FDA)
approved Amzeeq™ (minocycline topical foam) for
the treatment of inflammatory lesions of non-nodular
moderate to severe acne vulgaris in adults and pediatric
individuals 9 years of age and older. Source: FDA
website
|
New Formulation | 10-18-19 |
Trikafta
The Food and Drug Administration (FDA)
approved Trikafta™
(elexacaftor/ivacaftor/tezacaftor tablets) for the
treatment of cystic fibrosis (CF) in individuals 12
years and older who have at least 1 F508del mutation in
the cystic fibrosis transmembrane conductance regulator
modulator (CFTR) gene. Source: FDA website
|
New Drug | 10-21-19 |
Sanofi
Sanofi announced a voluntary recall of
all Zantac® (ranitidine oral) over-the-counter (OTC)
in the United States due to the potential for detection
of an unexpected impurity. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us
Source: FDA website
|
Drug Recall | 10-23-19 |
Dr Reddy's Laboratories
Dr. Reddy’s Laboratories announced a
voluntary recall of all its ranitidine medications sold
in the United States due to confirmed contamination with
N-Nitrosodimethylamine (NDMA). Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market
Source: FDA website
|
Drug Recall | 10-23-19 |
Perrigo Company
Perrigo Company announced a voluntary
recall of all package sizes of ranitidine due to the
possible presence of a nitrosamine impurity. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n
Source: FDA website
|
Drug Recall | 10-23-19 |
Keppra
The Food and Drug Administration (FDA)
approved Keppra® (levetiracetam tablets and
oral solution) as monotherapy in the treatment of
partial-onset seizures in individuals 1 month of age and
older. Source: FDA website
|
Expanded Indication | 10-23-19 |
Keppra XR
The Food and Drug Administration (FDA)
approved Keppra XR® (levetiracetam
extended-release tablets) as monotherapy in the
treatment of partial-onset seizures in individuals 12
years of age and older. Source: FDA website
|
Expanded Indication | 10-23-19 |
Vumerity
The Food and Drug Administration (FDA)
approved VumerityTM(diroximel fumarate
delayed-release capsules) for the treatment of relapsing
forms of multiple sclerosis (MS), to include clinically
isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, in adults. Source:
FDA website
|
New Drug | 10-29-19 |
Novitium Pharma
Novitium Pharma announced a voluntary
recall of all lots within expiry of ranitidine capsules
due to levels of N-Nitrosodimethylamine (NDMA) above the
levels recently established by the Food and Drug
Administration (FDA). Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg
Source: FDA website
|
Drug Recall | 10-28-19 |
Lannett Company
Lannett Company announced a voluntary
recall of all lots within expiry of ranitidine syrup 15
mg/mL due to levels of N-Nitrosodimethylamine (NDMA)
above the levels recently established by the Food and
Drug Administration (FDA). Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral-solution-usp-15mgml-due
Source: FDA website
|
Drug Recall | 10-25-19 |
Alprazolam
Mylan announced a voluntary recall of
one lot of alprazolam 0.5 mg tablets due to the presence
of a foreign substance. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05
Source: FDA website
|
Drug Recall | 10-26-19 |
Talicia
The Food and Drug Administration (FDA)
approved Talicia® (omeprazole
magnesium/amoxicillin/rifabutin delayed-release
capsules) approved for the treatment of Helicobacter
pylori (H. pylori) infection in adults. Source: FDA
website
|
New Formulation | 11-04-19 |
Fluzone High-Dose Quadrivalent
The Food and Drug Administration (FDA)
approved Fluzone® High-Dose Quadrivalent (influenza
vaccine injection) for use in adults 65 years of age and
older to prevent influenza disease caused by influenza A
and B strains contained in the vaccine. Source: FDA
website
|
New Formulation | 11-04-19 |
Reblozyl
The Food and Drug Administration (FDA)
approved Reblozyl® (luspatercept-aamt injection) for
the treatment of anemia in adults with beta thalassemia
who require regular red blood cell (RBC) transfusions.
Source: FDA website
|
New Drug | 11-08-19 |
Fetroja
The Food and Drug Administration (FDA)
approved Fetroja® (cefiderocol injection) for the
treatment of adults with complicated urinary tract
infection (cUTI), including pyelonephritis caused by
susceptible Gram-negative microorganisms, with limited
or no alternative treatment options. Source: FDA website
|
New Drug | 11-14-19 |
Brukinsa
The Food and Drug Administration (FDA)
approved Brukinsa™ (zanubrutinib capsules) for the
treatment of adults
with mantle cell lymphoma (MCL) who have received at
least one prior
therapy. Source: FDA website
|
New Drug | 11-14-19 |
American Health Packaging
American Health Packaging announced a
voluntary recall of eight lots of ranitidine syrup 150
mg/10 mL due to the detection of trace amounts of an
unexpected impurity. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral
Source: FDA website
|
Drug Recall | 11-08-19 |
Aurobindo
Aurobindo Pharma announced a voluntary
recall of one lot of ranitidine tablets 150 mg and
thirty-seven lots of ranitidine capsules 150 mg,
ranitidine capsules 300 mg, and ranitidine syrup 150
mg/mL due to the detection of N-nitrosodimethylamine
(NDMA). Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine
Source: FDA website
|
Drug Recall | 11-08-19 |
Amneal
Amneal announced a voluntary recall of
prescription ranitidine tablets 150 mg and 300 mg due to
unacceptable levels of N-nitrosodimethylamine (NDMA).
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg
Source: FDA website
|
Drug Recall | 11-12-19 |
Lets Gel Kit
Fagron announced a voluntary recall of
all unexpired lots of Lets Gel Kit™ (lidocaine
hydrochloride/epinephrine bitartrate/tetracaine
hydrochloride/sodium metabisulfite/suturagel
methylcellulose base/adapter cap/syringes) convenience
packs due to potential microbial contamination. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fagron-inc-issues-voluntary-nationwide-recall-lets-gel-kit-convenience-packs-due-potential-microbial
Source: FDA website
|
Drug Recall | 11-04-19 |
MiniMed Pumps
Medtronic announced a recall of
specified remote controllers used with MiniMed™
insulin pumps due to potential cybersecurity risks.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-remote-controllers-minimed-insulin-pumps-potential-cybersecurity-risks
Source: FDA website
|
Drug Recall | 11-05-19 |
Biotin
The Food and Drug Administration (FDA)
is reminding health care providers and consumers that
biotin can significantly interfere with certain lab
tests and cause incorrect results. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication
Source: FDA website
|
Drug Warning | 11-05-19 |
Calquence
The Food and Drug Administration (FDA)
approved Calquence® (acalabrutinib capsules) for the
treatment of adults with chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL). Source: FDA
website
|
New Indication | 11-21-19 |
Toujeo
The Food and Drug Administration (FDA)
approved Toujeo® (insulin glargine injection) to
include treatment of pediatric individuals aged 6 years
or older with diabetes mellitus. Source: FDA website
|
Expanded Indication | 12-02-19 |
Exservan
The Food and Drug Administration (FDA)
approved Exservan™ (riluzole oral film) for the
treatment of amyotrophic lateral sclerosis (ALS).
Source: FDA website
|
New Formulation | 11-22-19 |
RediTrex
The Food and Drug Administration (FDA)
approved RediTrex™ (methotrexate subcutaneous
injection) for the management of individuals with
severe, active rheumatoid arthritis (RA) and
polyarticular juvenile idiopathic arthritis (pJIA), who
are intolerant of or had an inadequate response to
first-line therapy. It is also indicated for symptomatic
control of severe, recalcitrant, disabling psoriasis in
adults who are not adequately responsive to other forms
of therapy. Source: FDA website
|
New Formulation | 12-02-19 |
Regenecare HA Hydrogel
MPM Medical announced a voluntary
recall of one lot of Regenecare® HA Hydrogel
(lidocaine topical) due to bacterial contamination.
Contact your health care provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mpm-medical-llc-issues-voluntary-nationwide-recall-regenecare-ha-hydrogel-due-burkholderia-cepecia
Source: FDA website
|
Drug Recall | 12-02-20 |
Adakveo
The Food and Drug Administration (FDA)
approved Adakveo® (crizanlizumab injection) to
reduce the frequency of vaso-occlusive crises in adults
and pediatric individuals aged 16 years and older with
sickle cell disease. Source: FDA website
|
New Drug | 11-15-19 |
Oxbryta
The Food and Drug Administration (FDA)
approved Oxbryta™ (voxelotor tablets) for adults
and pediatric individuals 12 years of age and older with
sickle cell disease. Source: FDA website
|
New Drug | 11-25-19 |
Givlaari
The Food and Drug Administration (FDA)
approved Givlaari™ (givosiran subcutaneous
injection) for the treatment of adults with acute
hepatic porphyria. Source: FDA website
|
New Drug | 11-20-19 |
Xcopri
The Food and Drug Administration (FDA)
approved Xcopri® (cenobamate tablets) for the
treatment of partial-onset seizures in adults. Source:
FDA website
|
New Drug | 11-21-19 |
Golden State Medical Supply
Golden State Medical announced a
voluntary recall of all lots within expiry of ranitidine
capsules 150 mg and 300 mg due to the potential presence
of N-nitrosodimethylamine (NDMA) above levels
established by the Food and Drug Administration (FDA).
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-150mg
Source: FDA website
|
Drug Recall | 11-19-19 |
Precision Dose
Precision Dose announced a voluntary
recall of 5 lots of ranitidine oral solution due to
potential N-nitrosodimethylamine (NDMA) amounts above
levels established by the Food and Drug Administration
(FDA). Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-ranitidine-oral-solution-usp-150-mg10-ml-due
Source: FDA website
|
Drug Recall | 11-21-19 |
Tecentriq
The Food and Drug Administration (FDA)
approved Tecentriq® (atezolizumab injection) for use
in combination with Abraxane®(paclitaxel
protein-bound injection) and carboplatin for first-line
treatment of adults with metastatic non-squamous
non-small cell lung cancer (NSCLC) with no epidermal
growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) genomic tumor aberrations. Source: FDA
website
|
New Indication | 12-04-19 |
Xeljanz XR
The Food and Drug Administration (FDA)
approved Xeljanz XR® (tofacitinib extended-relesae
tablets) for the treatment of adults with moderately to
severely active ulcerative colitis (UC) after an
inadequate response or intolerance to tumor necrosis
factor (TNF) blockers. Source: FDA website
|
New Indication | 12-13-19 |
Vascepa
The Food and Drug Administration (FDA)
approved Vascepa® (icosapent ethyl capsules) as an
adjunctive therapy to reduce the risk of cardiovascular
(CV) events among adults with elevated triglyceride
levels of 150 milligrams per deciliter or higher.
Individuals must also have either established CV disease
or diabetes and two or more additional risk factors for
CV disease. Source: FDA website
|
New Indication | 12-13-19 |
Vyondys 53
The Food and Drug Administration (FDA)
approved Vyondys 53™ (golodirsen injection) for
the treatment of Duchenne muscular dystrophy (DMD) in
individuals who have a confirmed mutation of the DMD
gene that is amenable to exon 53 skipping. Source: FDA
website
|
New Drug | 12-13-19 |
Unapproved stem cell and exosome products
The Food and Drug Administration (FDA
is warning consumers of reports of serious adverse
events due to marketing of unapproved stem cell and
exosome products. Contact your health care provider with
questions. More details may be viewed at:
https://www.fda.gov/about-fda/medical-product-safety-information/public-safety-alert-due-marketing-unapproved-stem-cell-and-exosome-products
Source: FDA website
|
Drug Warning | 12-10-19 |
Basic Reset and Biogenyx
The Food and Drug Administration (FDA)
alerted consumers of a recall of 25 drug, dietary
supplement, and medical device product lines distributed
by Basic Reset and Biogenyx due to not meeting FDA
regulations. Contact your health care provider with
questions. More details may be viewed at:
https://www.fda.gov/news-events/press-announcements/fda-underscores-consumers-should-not-use-drugs-dietary-supplements-and-devices-recalled-basic-reset
Source: FDA website
|
Drug Recall | 12-10-19 |
Xtandi
The Food and Drug Administration (FDA)
approved Xtandi® (enzalutamide capsules) for
individuals with metastatic castration-sensitive
prostate cancer (mCSPC). Source: FDA website
|
Expanded Indication | 12-16-19 |
Fiasp
The Food and Drug Administration (FDA)
approved Fiasp® (insulin aspart injection) for use
as a new mealtime insulin option for children with
diabetes. Source: FDA website
|
Expanded Indication | 12-19-19 |
Mycamine
The Food and Drug Administration (FDA)
approved Mycamine™ (micafungin sodium injection)
for the treatment of candidemia, acute disseminated
candidiasis, Candida peritonitis and abscesses without
meningoencephalitis and/or ocular dissemination in
pediatric individuals younger than 4 months of age.
Source: FDA website
|
Expanded Indication | 12-20-19 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) for the
maintenance treatment of adults with deleterious or
suspected deleterious germline BRCA-mutated (gBRCAm)
metastatic pancreatic adenocarcinoma whose disease has
not progressed on at least 16 weeks of a first-line
platinum-based chemotherapy regimen. Individuals will be
selected for therapy based on an FDA-approved companion
diagnostic.. Source: FDA website
|
New Indication | 12-30-19 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) for the
treatment of individuals with Bacillus Calmette-Guerin
(BCG)-unresponsive, high-risk, non-muscle invasive
bladder cancer (NMIBC) with carcinoma in situ (CIS) with
or without papillary tumors who are ineligible for or
have elected not to undergo cystectomy. Source: FDA
website
|
New Indication | 01-08-20 |
Arazlo
The Food and Drug Administration (FDA)
approved Arazlo™ (tazarotene lotion) for the
topical treatment of acne vulgaris in individuals 9
years of age and older. Source: FDA website
|
New Formulation | 12-18-19 |
Conjupri
The Food and Drug Administration (FDA)
approved Conjupri® (levamlodipine tablets) for the
treatment of hypertension. Source: FDA website
|
New Formulation | 12-20-19 |
Ervebo
The Food and Drug Administration (FDA)
approved Ervebo® (Ebola virus vaccine injection) for
the prevention of Ebola virus disease caused by Zaire
ebolavirus in individuals 18 years of age and older.
Source: FDA website
|
New Vaccine | 12-20-19 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for the third-line treatment of adults with
unresectable or metastatic HER2-positive breast cancer.
Source: FDA website
|
New Drug | 12-20-19 |
Caplyta
The Food and Drug Administration (FDA)
approved Caplyta® (lumateperone capsules) for the
treatment of schizophrenia in adults Source: FDA website
|
New Drug | 12-20-19 |
Dayvigo
The Food and Drug Administration (FDA)
approved Dayvigo™ (lemborexant tablets) for the
treatment of adults with insomnia that is characterized
by difficulties with sleep onset and/or sleep
maintenance. Source: FDA website
|
New Drug | 12-20-19 |
Ubrelvy
The Food and Drug Administration (FDA)
approved Ubrelvy™ (ubrogepant tablets) for the
treatment of acute migraines that present with or
without aura in adults. Source: FDA website
|
New Drug | 12-23-19 |
Padcev
The Food and Drug Administration (FDA)
approved Padcev™ (enfortumab vedotin-ejfv
injection) for the treatment of adults with locally
advanced or metastatic urothelial cancer who have
previously received a programmed death receptor-1 (PD-1)
or programmed death-ligand 1 (PD-L1) inhibitor, and a
platinum-containing chemotherapy in the
neoadjuvant/adjuvant, locally advanced or metastatic
setting. Source: FDA website
|
New Drug | 12-18-19 |
Ayvakit
The Food and Drug Administration (FDA)
approved Ayvakit™ (avapritinib tablets) for the
treatment of adults with unresectable or metastatic
PDGFRA exon 18 mutant gastrointestinal stromal tumor
(GIST). Source: FDA website
|
New Drug | 01-09-19 |
Mavidon
Mavidon announced a voluntary recall
of all lots of products manufactured at their facility
including due to contamination with Burkholderia
cepacia. Contact your healthcare provider with
questions. More details including affected products may
be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-all-manufactured-products-due-burkholderia-cepacia
Source: FDA website
|
Drug Recall | 12-26-19 |
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals announced a
voluntary recall of prescription ranitidine 150 mg and
300 mg tablets because they may contain unacceptable
levels of N-nitrosodimethylamine (NDMA). Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-voluntarily-recalls-all-unexpired-lots-its-ranitidine-tablets-and
Source: FDA website
|
Drug Recall | 12-18-19 |
Mirtazapine
Aurobindo announced a voluntary recall
of one lot of mirtazapine tablets due to a label error
on declared strength. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number
Source: FDA website
|
Drug Recall | 01-02-20 |
Levetiracetam
Lannett Company announced a voluntary
recall of two lots of levetiracetam oral solution due to
contamination with Bacillus subtilis. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-levetiracetam-oral-solution-100mgml-due-microbial
Source: FDA website
|
Drug Recall | 12-20-19 |
Denton Pharma
Denton Pharma, doing business as
Northwind Pharmaceuticals, announced a voluntary recall
of all unexpired lots of ranitidine tablets due to
potential presence of the impurity
N-nitrosodimethylamine (NDMA). Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/denton-pharma-inc-dba-northwind-pharmaceuticals-voluntarily-recalls-all-unexpired-lots-its
Source: FDA website
|
Drug Recall | 01-08-20 |
Nizatidine
Mylan announced a voluntary recall of
3 lots of nizatidine capsules due to detected trace
amounts of an impurity N-nitrosodimethylamine (NDMA).
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace
Source: FDA website
|
Drug Recall | 01-08-20 |
Appco Pharma
Appco Pharma announced a voluntary
recall of all quantities and lots within expiry of
ranitidine capsules due to the presence or potential
presence of N-nitrosodimethylamine (NDMA) levels above
those established as acceptable by the Food and Drug
Administration (FDA). Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/appco-pharma-llc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-capsules-150-mg-and-300
Source: FDA website
|
Drug Recall | 01-08-20 |
Gabapentin and pregabalin
The Food and Drug Administration (FDA)
is warning that serious breathing difficulties may occur
in individuals using gabapentin or pregabalin who have
respiratory risk factors. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin
Source: FDA website
|
Drug Warning | 12-19-19 |
Ozempic
The Food and Drug Administration (FDA)
approved Ozempic® (semaglutide injection) for
reducing the risk of major adverse cardiovascular events
(MACE) including cardiovascular death, non-fatal heart
attack, or non-fatal stroke in adults with type 2
diabetes and established cardiovascular disease (CVD).
Source: FDA website
|
Expanded Indication | 01-16-20 |
Valtoco
The Food and Drug Administration (FDA)
approved Valtoco® (diazepam nasal spray) for the
acute treatment of intermittent, stereotypic episodes of
frequent seizure activity (ie, seizure clusters, acute
repetitive seizures) that are distinct from a patient’s
usual seizure pattern in individuals with epilepsy 6
years of age and older. Source: FDA website
|
New Formulation | 01-13-20 |
Monoferric
The Food and Drug Administration (FDA)
approved Monoferric™ (ferric derisomaltose
injection) for the treatment of iron deficiency anemia
in adults who have intolerance to oral iron or have had
unsatisfactory response to oral iron or who have
non-hemodialysis dependent chronic kidney disease.
Source: FDA website
|
New Formulation | 01-16-20 |
Lamotrigine
Taro Pharmaceuticals announced a
voluntary recall of one lot of lamotrigine 100 mg
tablets due to cross contamination with a small amount
of another drug substance (enalapril maleate) used to
manufacture another product at the same facility.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-lamotrigine-tablets-usp-100-mg-100
Source: FDA website
|
Drug Recall | 01-10-20 |
AXIA Pharmaceutical
AXIA Pharmaceutical announced a
voluntary recall of all unused sterile drug products
within expiry due to a lack of assurance of sterility.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-iv-pharmaceuticals-inc-dba-axia-pharmaceutical-issues-voluntary-nationwide-recall-all-sterile
Source: FDA website
|
Drug Recall | 01-17-20 |
Lorcaserin
The Food and Drug Administration (FDA)
is warning that results from a clinical trial assessing
safety show a possible increased risk of cancer with the
weight management medication Belviq® (lorcaserin
tablets) and Belviq XR® (lorcaserin extended release
tablets). It cannot yet be concluded that lorcaserin
contributes to the cancer risk. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-drug-safety-communication-due-possible-increased-risk-cancer
Source: FDA website
|
Drug Warning | 01-14-20 |
Tepezza
The Food and Drug Administration (FDA)
approved Tepezza™ (teprotumumab-trbw injection)
for the treatment of thyroid eye disease (TED). Source:
FDA website
|
New Drug | 01-21-20 |
Tazverik
The Food and Drug Administration (FDA)
approved Tazverik™ (tazemetostat tablets) for the
treatment of adults and pediatric individuals aged 16
years and older with metastatic or locally advanced
epithelioid sarcoma who are not eligible for complete
resection. Source: FDA website
|
New Drug | 01-23-20 |
FUSION IV Pharmaceuticals
FUSION IV Pharmaceuticals announced a
voluntary recall of all unused sterile drug products
within expiry due to a lack of assurance of sterility.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-iv-pharmaceuticals-inc-dba-axia-pharmaceutical-issues-voluntary-nationwide-recall-all-sterile
Source: FDA website
|
Drug Recall | 01-21-20 |
ABH Nature's Products, ABH Pharma, and
Stocknutra.com
ABH Nature's Products, ABH Pharma, and
Stocknutra.com announced a voluntary recall of all lots
of dietary supplement products manufactured and sold
between January 2013 and November 2019 due to
significant violations of current good manufacturing
practice regulations. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abh-natures-products-inc-abh-pharma-inc-and-stocknutracom-inc-issues-nationwide-recall-all-lots
Source: FDA website
|
Drug Recall | 01-23-20 |
Dificid
The Food and Drug Administration (FDA)
approved Dificid® (fidaxomicin tablets) for use in
pediatric individuals 6 months of age and older for the
treatment of Clostridioides difficile (C. difficile)
associated diarrhea (CDAD). The approval includes a new
oral suspension formulation. Source: FDA website
|
Expanded Indication | 01-27-20 |
Sabril
The Food and Drug Administration (FDA)
approved Sabril® (vigabatrin tablets) for use in
individuals 2 years of age and older with refractory
complex partial seizures. Source: FDA website
|
Expanded Indication | 01-24-20 |
Invokamet, Invokamet XR
The Food and Drug Administration (FDA)
approved Invokamet® (canagliflozin/metformin
tablets) and Invokamet® XR (canagliflozin/metformin
extended release tablets) to reduce the risk of
end-stage kidney disease, doubling of serum creatinine,
cardiovascular death, and hospitalization for heart
failure in adults with type 2 diabetes mellitus and
diabetic nephropathy with albuminuria. Source: FDA
website
|
Expanded Indication | 01-27-20 |
Trijardy XR
The Food and Drug Administration (FDA)
approved Trijardy™ XR
(empagliflozin/linagliptin/metformin hydrochloride
extended release tablets) to lower blood sugar in adults
with type 2 diabetes, along with diet and exercise.
Source: FDA website
|
New Formulation | 01-27-20 |
Ajovy Autoinjector
The Food and Drug Administration (FDA)
approved Ajovy® (fremanezumab autoinjector) for the
preventive treatment of migraine in adults. Source: FDA
website
|
New Formulation | 01-28-20 |
Bynfezia Pen
The Food and Drug Administration (FDA)
approved Bynfezia Pen™ (octreotide acetate
subcutaneous injection) for reduction of growth hormone
(GH) and insulin-like growth factor 1 (IGF-1)
[somatomedin C] in adults with acromegaly who have had
inadequate response to or cannot be treated with
surgical resection, pituitary irradiation, and
bromocriptine mesylate at maximally tolerated doses. It
is also approved for treatment of severe
diarrhea/flushing episodes associated with metastatic
carcinoid tumors in adults and for treatment of profuse
watery diarrhea associated with vasoactive intestinal
peptide tumors (VIPomas) in adults. Source: FDA website
|
New Formulation | 01-28-20 |
Audenz
The Food and Drug Administration (FDA)
approved Audenz™ (influenza A H5N1 monovalent
vaccine injection) for active immunization for the
prevention of disease in individuals 6 months of age and
older at increased risk of exposure to the influenza A
H5N1 virus subtype contained in the vaccine. Source: FDA
website
|
New Formulation | 02-03-20 |
Palforzia
The Food and Drug Administration (FDA)
approved Palforzia™ (peanut allergen oral powder)
for the mitigation of allergic reactions, including
anaphylaxis, that may occur with accidental exposure to
peanut. Source: FDA website
|
New Drug | 01-31-20 |
Rompe Pecho EX, Rompe Pecho CF, and Rompe
Pecho MAXliquid
Efficient Laboratories announced a
voluntary recall of three lots of Rompe Pecho EX, Rompe
Pecho CF, and Rompe Pecho MAXliquid. These products are
used to treat symptoms of the flu and the common cold.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-issues-voluntary-nationwide-recall-rompe-pecho-ex-rompe-pecho-cf-and
Source: FDA website
|
Drug Recall | 02-03-20 |
Clozapine
The Food and Drug Administration (FDA)
is strengthening an existing warning that constipation
caused by the schizophrenia medication clozapine can
progress to serious bowel complications. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/medical-product-safety-information/clozaril-fazaclo-odt-versacloz-clozapine-drug-safety-communication-fda-strengthens-warning-untreated
Source: FDA website
|
Drug Warning | 01-28-20 |
Pemfexy
The Food and Drug Administration (FDA)
approved Pemfexy™ (pemetrexed injection)
ready-to-dilute formulation for locally advanced or
metastatic nonsquamous non-small cell lung cancer in
combination with cisplatin; locally advanced or
metastatic nonsquamous non-small cell lung cancer whose
disease has not progressed after four cycles of
platinum-based first-line chemotherapy, as maintenance
treatment; locally advanced or metastatic nonsquamous
non-small cell lung cancer after prior chemotherapy as a
single agent; and malignant pleural mesothelioma whose
disease is unresectable or who are otherwise not
candidates for curative surgery in combination with
cisplatin. Source: FDA website
|
New Formulation | 02-14-20 |
Twirla
The Food and Drug Administration (FDA)
approved Twirla® (levonorgestrel/ethinyl estradiol
transdermal) as a method of contraception for use in
women of reproductive potential with a BMI < 30 kg/m2
for whom a combined hormonal contraceptive is
appropriate. Source: FDA website |
New Formulation | 02-14-20 |
Pizensy
The Food and Drug Administration (FDA)
approved Pizensy (lactitol powder for oral solution) for
the treatment of chronic idiopathic constipation in
adults. Source: FDA website
|
New Formulation | 02-12-20 |
Anagrelide
Torrent Pharmaceuticals announced a
voluntary recall of one lot of anagrelide capsules due
to dissolution test failure. Contact your health care
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-anagrelide-capsules-usp-due
Source: FDA website
|
Drug Recall | 12-09-20 |
Anjeso
The Food and Drug Administration (FDA)
approved Anjeso™ (meloxicam injection) for the
management of moderate-to-severe pain, alone or in
combination with other non-non-steroidal
anti-inflammatory drugs (NSAIDs). Source: FDA website
|
New Formulation | 02-20-20 |
Nexletol
The Food and Drug Administration (FDA)
approved Nexletol™ (bempedoic acid tablets) as an
adjunct to diet and maximally tolerated statin therapy
for the treatment of adults with heterozygous familial
hypercholesterolemia or established atherosclerotic
cardiovascular disease who require additional lowering
of low-density lipoprotein cholesterol (LDL-C). Source:
FDA website
|
New Drug | 02-21-20 |
MiniMed 600 Series insulin pumps
Medtronic announced a voluntary recall
of certain MiniMed 600 Series insulin pumps due to a
missing or broken retainer ring. Contact your healthcare
provider with questions. More details including affected
pumps may be viewed at:
https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing
Source: FDA website
|
Drug Recall | 02-12-20 |
Belviq; Belviq XR
Eisai has decided to withdraw the
weight loss drugs Belviq® (lorcaserin tablets) and
Belviq XR® (lorcaserin extended-release tablets)
from the market. This is based on a recently completed
analysis of data from the CAMELLIA-TIMI 61 trial. The
Food and Drug Administration (FDA) is advising
healthcare professionals to stop prescribing lorcaserin
and to contact those who have been treated with the
drug. Individuals should be informed of the increased
occurrence of cancer seen in the clinical trial. Source:
FDA website; Eisai website
|
Drug Withdrawal | 02-14-20 |
Voltaren Arthritis Pain
The Food and Drug Administration (FDA)
approved Voltaren Arthritis Pain (diclofenac topical 1%
gel) for over-the-counter (OTC) use for the temporary
relief of arthritis pain. Source: FDA website
|
New OTC | 02-17-20 |
Pataday Twice Daily Relief
The Food and Drug Administration (FDA)
approved Pataday® Twice Daily Relief (olopatadine
hydrochloride ophthalmic 0.1% solution and drops) for
over-the-counter (OTC) use for the temporary relief of
itchy and red eyes due to pollen, ragweed, grass, animal
hair, or dander. Source: FDA website
|
New OTC | 02-17-20 |
Pataday Once Daily Relief
The Food and Drug Administration (FDA)
approved Pataday® Once Daily Relief (olopatadine
hydrochloride ophthalmic 0.2% solution and drops) for
over-the-counter (OTC) use for the temporary relief of
itchy and red eyes due to pollen, ragweed, grass, animal
hair, or dander. Source: FDA website
|
New OTC | 02-17-20 |
Trulicity
The Food and Drug Administration (FDA)
approved Trulicity® (dulaglutide injection) for the
reduction of cardiovascular (CV) risks in individuals
with type 2 diabetes. Source: FDA website
|
Expanded Indication | 02-14-20 |
Nerlynx
The Food and Drug Administration (FDA)
approved Nerlynx® (neratinib tablets) in combination
with capecitabine for the treatment of adults with
advanced or metastatic human epidermal growth factor
receptor 2 (HER2)-positive breast cancer who have
received two or more prior anti-HER2-based regimens in
the metastatic setting. Source: FDA website
|
Expanded Indication | 02-26-20 |
Fluad Quadrivalent
The Food and Drug Administration (FDA)
approved Fluad® Quadrivalent (influenza vaccine
injection) for active immunization against influenza
disease caused by influenza virus subtypes A and types B
contained in the vaccine in individuals 65 years of age
and older. Source: FDA website
|
Expanded Indication | 02-24-20 |
ArmonAir Digihaler
The Food and Drug Administration (FDA)
approved ArmonAir® Digihaler™ (fluticasone
propionate oral inhalation powder) for the maintenance
treatment of asthma in individuals 12 years and older.
Source: FDA website
|
New Formulation | 02-24-20 |
Nexlizet
The Food and Drug Administration (FDA)
approved Nexlizet™ (bempedoic acid/ezetimibe
tablets) as an adjunct to diet and maximally tolerated
statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia or
established atherosclerotic cardiovascular disease who
require additional lowering of low-density lipoprotein
cholesterol (LDL)-C. Source: FDA website
|
New Formulation | 02-26-20 |
Barhemsys
The Food and Drug Administration (FDA)
approved Barhemsys® (amisulpride injection) for the
treatment of postoperative nausea and vomiting in
individuals who have received antiemetic prophylaxis
with an agent of a different class or who have not
received prophylaxis. It is also approved for the
prevention of postoperative nausea and vomiting, either
alone or in combination with an antiemetic of a
different class. Source: FDA website
|
New Drug | 02-27-20 |
Nurtec
The Food and Drug Administration (FDA)
approved Nurtec® (rimegepant orally disintegrating
tablets) for the acute treatment of migraine in adults.
Source: FDA website
|
New Drug | 02-27-20 |
Vyepti
The Food and Drug Administration (FDA)
approved Vyepti™ (eptinezumab injection) for the
preventive treatment of migraine in
adults. Source: FDA website
|
New Drug | 02-21-20 |
American Health Packaging
American Health Packaging announced a
voluntary recall of eleven lots of ranitidine tablets
due to the potential for N-Nitrosodimethylamine (NDMA)
amounts above levels established by the Food and Drug
Administration (FDA). Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150-mg-100-count
Source: FDA website
|
Drug Recall | 02-27-20 |
Phenytoin
Taro Pharmaceuticals announced a
voluntary recall of two lots of phenytoin oral
suspension due to possible underdosing or overdosing.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-phenytoin-oral-suspension-usp-125-mg5ml
Source: FDA website
|
Drug Recall | 02-21-20 |
Symtuza
The Food and Drug Administration (FDA)
approved Symtuza®
(darunavir/cobicistat/emtricitabine/tenofovir
alafenamide tablets) for the treatment of human
immunodeficiency virus (HIV)-1 infection in pediatric
individuals weighing at least 40kg who are
treatment-naive or virologically suppressed (<50
copies/mL) on a stable antiretroviral regimen
for at least 6 months and have no known
substitutions associated with resistance to
darunavir or tenofovir. Source: FDA website
| Expanded Indication | 03-05-20 |
Durysta
The Food and Drug Administration (FDA)
approved Durysta™ (bimatoprost ophthalmic implant)
for the reduction of intraocular pressure (IOP) in
individuals with open angle glaucoma (OAG) or ocular
hypertension (OHT). Source: FDA website
|
New Formulation | 03-05-20 |
Sarclisa
The Food and Drug Administration (FDA)
approved Sarclisa® (isatuximab injection) for the
treatment of adults with multiple myeloma, in
combination with pomalidomide and dexamethasone, who
have received at least two prior therapies. Source: FDA
website
|
New Drug | 03-02-20 |
Saxenda
The Food and Drug Administration (FDA)
approved Saxenda® (liraglutide injection) for
chronic weight management among individuals aged 12 and
older who are obese, as defined by specific body mass
index (BMI) cut-offs for age and sex that correspond to
a BMI 30 kg/m2 or higher for adults, and who weigh more
than 60 kg (132 pounds). Saxenda is an adjunct to a
reduced-calorie diet and greater physical activity.
Source: FDA website
|
New Indication | 12-04-20 |
Ketorolac tromethamine
Hikma Pharmaceuticals announced an
expansion of a previous voluntary recall of certain lots
of ketorolac tromethamine injection due to the presence
of particulate matters. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-ketorolac-tromethamine-injection
Source: FDA website
|
Drug Recall | 03-05-20 |
Singulair
The Food and Drug Administration (FDA)
announced it is requiring a boxed warning for
Singulair® (montelukast tablets and oral granules)
and its generics to strengthen an existing warning about
the risk of neuropsychiatric events associated with this
asthma and allergic rhinitis medication. The new warning
will advise against prescribing it for individuals with
mild symptoms, particularly those with allergic
rhinitis. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use
Source: FDA website
|
Drug Warning | 03-04-20 |
Isturisa
The Food and Drug Administration (FDA)
approved Isturisa® (osilodrostat tablets) for the
treatment of Cushing’s disease in adults for whom
pituitary surgery is not an option or was unsuccessful.
Source: FDA website
|
New Drug | 03-06-20 |
Ofev
The Food and Drug Administration (FDA)
approved Ofev® (nintedanib capsules) to treat
individuals with chronic fibrosing interstitial lung
diseases (ILD) with a progressive phenotype. Source: FDA
website
|
New Indication | 03-09-20 |
Opdivo and Yervoy
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) and Yervoy®
(ipilimumab injection) to treat hepatocellular carcinoma
(HCC) in patients who have been previously treated with
sorafenib. Source: FDA website
|
New Indication | 03-11-20 |
Epclusa
The Food and Drug Administration (FDA)
approved Epclusa® (sofosbuvir/velpatasvir tablets) to
treat hepatitis C virus (HCV) in children ages 6 years
and older or weighing at least 37 pounds with any of the
six HCV genotypes without cirrhosis or with mild
cirrhosis. Epclusa in combination with ribavirin is
indicated for the treatment of children 6 years and
older or weighing at least 37 pounds with severe
cirrhosis. Source: FDA website
|
Expanded Indication | 03-19-20 |
Eucrisa
The Food and Drug Administration (FDA)
approved Eucrisa® (crisaborole ointment) for the
treatment of mild to moderate atopic dermatitis in
pediatric individuals as young as 3 months old. Source:
FDA website
|
Expanded Indication | 03-24-20 |
EpiPen; EpiPen Jr
The Food and Drug Administration (FDA)
is alerting consumers and healthcare providers that
EpiPen® (epinephrine 0.3 mg) and EpiPen Jr® (epinephrine
0.15 mg) auto-injectors, and authorized generic
versions, may have delayed injection or be prevented
from properly injecting. Contact your healthcare
provider with questions. More details may be viewed
at:https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-epipen-auto-injector-errors-related-device
Source: FDA website
|
Drug Warning | 03-24-20 |
Zeposia
The Food and Drug Administration (FDA)
approved Zeposia® (ozanimod capsules) for the treatment
of relapsing forms of multiple sclerosis (MS) to include
clinically isolated syndrome, relapsing-remitting
disease, and active secondary progressive disease.
Source: FDA website
|
New Drug | 03-25-20 |
Phytonadione
Dr. Reddy’s announced a voluntary
recall of phytonadione injectable emulsion 10 mg/mL
single-dose ampules due to breaking and shattering upon
opening. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10
Source: FDA website
|
Drug Recall | 03-26-20 |
Taltz
The Food and Drug Administration (FDA)
approved Taltz® (ixekizumab injection) for the treatment
of pediatric individuals 6 years of age and older with
moderate to severe plaque psoriasis who are candidates
for systemic therapy or phototherapy. Source: FDA
website
|
Expanded Indication | 03-27-20 |
Imfinzi
The Food and Drug Administration (FDA)
approved Imfinzi® (durvalumab injection) as a first-line
treatment for adults with extensive-stage small cell
lung cancer (ES-SCLC) in combination with
standard-of-care (SoC) chemotherapies, etoposide plus
either carboplatin or cisplatin (platinum-etoposide).
Source: FDA website
|
New Indication | 03-27-20 |
Triferic
The Food and Drug Administration (FDA)
approved Triferic® (ferric pyrophosphate citrate
injection) for the replacement of iron to maintain
hemoglobin in adults with hemodialysis-dependent chronic
kidney disease (HDD-CKD). Source: FDA website
|
New Formulation | 03-27-20 |
Sevenfact
The Food and Drug Administration (FDA)
approved Sevenfact® [coagulation factor VIIa
(recombinant)-jncw injection] for the treatment and
control of bleeding episodes occurring in adults and
adolescents (12 years of age and older) with hemophilia
A or B with inhibitors. Source: FDA website
|
New Drug | 04-01-20 |
Ranitidine
The Food and Drug Administration (FDA)
is requesting manufacturers to withdraw all prescription
and over-the-counter (OTC) ranitidine drugs from the
market immediately. This is the latest step in an
ongoing investigation of a contaminant known as
N-Nitrosodimethylamine (NDMA) in ranitidine medications.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal
Source: FDA website
|
Drug Warning | 04-01-20 |
Reblozyl
The Food and Drug Administration (FDA)
approved Reblozyl® (luspatercept-aamt injection) for the
treatment of anemia failing an erythropoiesis
stimulating agent and requiring 2 or more red blood cell
(RBC) units over 8 weeks in adults with very low- to
intermediate-risk myelodysplastic syndromes with ring
sideroblasts (MDS-RS) or with
myelodysplastic/myeloproliferative neoplasm with ring
sideroblasts and thrombocytosis (MDS/MPN-RS-T). Source:
FDA website
|
New Indication | 04-03-20 |
Braftovi
The Food and Drug Administration (FDA)
approved Braftovi® (encorafenib capsules) in combination
with cetuximab for the treatment of Brafv600E-mutant
metastatic colorectal cancer (CRC) after prior therapy.
Source: FDA website
|
New Indication | 04-08-20 |
Koselugo
The Food and Drug Administration (FDA)
approved KoselugoTM (selumetinib capsules) for the
treatment of children 2 years of age and older with
neurofibromatosis type 1 (NF1) and symptomatic,
inoperable plexiform neurofibromas (PNs). Source: FDA
website
|
New Drug | 04-10-20 |
Ivermectin
There has been increased public
visibility of the antiparasitic drug ivermectin after
the announcement of a research article that described
the effect of ivermectin on SARS-CoV-2 in a laboratory
setting. The Food and Drug Administration (FDA) is
concerned about the health of consumers who may
self-medicate by taking ivermectin products intended for
animals. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ivermectin-intended-animals-letter-stakeholders-do-not-use-humans-treatment-covid-19
Source: FDA website
|
Drug Warning | 04-11-20 |
Fecal microbiota for transplantation
Due to the potential risk of
transmission of SARS-CoV-2 via fecal microbiota for
transplantation (FMT), the Food and Drug Administration
(FDA) has determined that additional protections are
needed for any investigational use of FMT. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-new-safety-information-regarding-additional-protections-screening
Source: FDA website
|
Drug Warning | 04-11-20 |
Senna laxatives
Magno-Humphries Laboratories announced
a voluntary recall of one lot of Basic Drugs Brand of
Senna laxative tablets due to mislabeling. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/magno-humphries-laboratories-inc-issues-voluntary-nationwide-recall-basic-drugs-brand-senna-laxative
Source: FDA website
|
Drug Recall | 04-15-20 |
Limbrel
Primus Pharmaceuticals announced a
voluntary recall of all lots within expiry of the
prescription medical food Limbrel® (flavocoxid capsules)
due to rare but serious and reversible adverse events.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/primus-announces-voluntary-nationwide-recall-all-lots-within-expiry-prescription-medical-food
Source: FDA website
|
Drug Recall | 04-15-20 |
Nizatidine
Amneal Pharmaceuticals announced a
voluntary recall of three lots of nizatidine oral
solution due to potential N-Nitrosodimethylamine (NDMA)
amounts exceeding levels established by the Food and
Drug Administration (FDA). Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-nizatidine-oral-solution-15-mgml-due
Source: FDA website
|
Drug Recall | 04-15-20 |
Gericare Eye Wash
Kareway Products announced a voluntary
recall of Gericare Eye Wash due to potential microbial
contamination. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kareway-products-inc-issues-voluntary-nationwide-recall-gericare-eye-wash-due-complaints-received
Source: FDA website
|
Drug Recall | 04-15-20 |
Jelmyto
The Food and Drug Administration (FDA)
approved JelmytoTM (mitomycin for pyelocalyceal
solution) for the treatment of adults with low-grade
upper tract urothelial cancer (LG-UTUC). Source: FDA
website
|
New Formulation | 04-15-20 |
Epclusa
The Food and Drug Administration (FDA)
approved Epclusa® (sofosbuvir/velpatasvir tablets) to
treat hepatitis C virus (HCV) in children ages 6 years
and older or weighing at least 37 pounds with any of the
six HCV genotypes-or strains-without cirrhosis or with
mild cirrhosis. Source: FDA website
|
Expanded Indication | 04-15-20 |
Tetracycline
Avet Pharmaceuticals announced a
voluntary recall of tetracycline 250 mg and 500 mg
capsules due to failed dissolution specifications.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avet-pharmaceuticals-inc-issues-voluntary-nationwide-recall-tetracycline-hcl-capsules-usp-250-mg-and
Source: FDA website
|
Drug Recall | 04-17-20 |
Clopidogrel
International Laboratories announced a
voluntary recall of one lot of clopidogrel 75 mg tablets
due to mislabeling. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/international-laboratories-llc-issues-voluntary-nationwide-recall-one-1-lot-clopidogrel-tablets-usp
Source: FDA website
|
Drug Recall | 04-17-20 |
Tukysa
The Food and Drug Administration (FDA)
approved TukysaTM (tucatinib tablets) for second-line or
greater treatment of adults with advanced unresectable
or metastatic human epidermal growth factor receptor 2
(HER2)-positive breast cancer, including individuals
with brain metastases, in combination with trastuzumab
and capecitabine. Source: FDA website
|
New Drug | 04-17-20 |
Pemazyre
The Food and Drug Administration (FDA)
approved PemazyreTM (pemigatinib tablets) for treatment
of adults with previously treated, unresectable locally
advanced or metastatic cholangiocarcinoma with an FGFR2
fusion or other rearrangement detected by FDA-approved
test. Source: FDA website
|
New Drug | 04-17-20 |
Cymbalta
The Food and Drug Administration (FDA)
approved Cymbalta® (duloxetine capsules) for the
treatment of fibromyalgia in individuals 13 to 17 years
of age. Source: FDA website
|
Expanded Indication | 04-20-20 |
Ketorolac tromethamine
Fresenius Kabi USA announced a
voluntary recall of 13 lots of ketorolac tromethamine
injection due to the presence of particulate matter.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-13-lots-ketorolac-tromethamine-injection-usp-due
Source: FDA website
|
Drug Recall | 04-20-20 |
Ceftazidime and dextrose
Braun Medical Inc. announced a
voluntary recall of 1 lot of ceftazidime and dextrose
for injection due to out-of-specification stability test
results for high molecular weight polymers. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-one-1-lot-ceftazidime-injection-usp-and
Source: FDA website
|
Drug Recall | 04-20-20 |
Imbruvica
The Food and Drug Administration (FDA)
approved Imbruvica® (ibrutinib tablets and capsules) to
include combination use with rituximab for the initial
treatment of adults with chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL). Source: FDA
website
|
Expanded Indication | 04-21-20 |
True Metrix Air
Trividia Health announced a voluntary
recall of 1 isolated True Metrix Air blood glucose meter
due to being packaged into a True Metrix blood glucose
meter kit and having an incorrect factory-set unit of
measure. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-issues-nationwide-voluntary-recall-isolated-true-metrix-air-blood-glucose-meter
Source: FDA website
|
Drug Recall | 04-21-20 |
Trodelvy
The Food and Drug Administration (FDA)
approved TrodelvyTM (sacituzumab govitecan-hziy
injection) for third-line or greater treatment of adults
with metastatic triple-negative breast cancer (TNBC).
Source: FDA website
|
New Drug | 04-22-20 |
Cannabidiol
The Food and Drug Administration (FDA)
has sent warning letters to 2 companies for illegally
selling unapproved products containing cannabidiol
(CBD). Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products-treat-medical-conditions-opioid-addiction
Source: FDA website
|
Drug Warning | 04-23-20 |
Hydroxychloroquine and chloroquine
The Food and Drug Administration (FDA)
is reminding health care providers and consumers that
hydroxychloroquine and chloroquine should not be used
inappropriately to treat non-hospitalized patients for
coronavirus disease (COVID-19) or to prevent the
disease. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/hydroxychloroquine-or-chloroquine-covid-19-drug-safety-communication-fda-cautions-against-use
Source: FDA website
|
Drug Warning | 04-24-20 |
Ongentys
The Food and Drug Administration (FDA)
approved Ongentys® (opicapone capsules) as add-on
treatment for individuals with Parkinson's disease
experiencing "off" episodes. Source: FDA website
|
New Drug | 04-24-20 |
MenQuadfi
The Food and Drug Administration (FDA)
approved MenQuadfiTM (meningococcal groups A, C, Y, W
conjugate vaccine injection) for the prevention of
invasive meningococcal disease in persons 2 years of age
and older. Source: FDA website
|
New Formulation | 04-24-20 |
Jublia
The Food and Drug Administration (FDA)
approved Jublia® (efinaconazole topical solution) for
the treatment of onychomycosis in children six years and
older. Source: FDA website
|
Expanded Indication | 04-26-20 |
Zejula
The Food and Drug Administration (FDA)
approved Zejula® (niraparib capsules) for the
maintenance treatment of adults with advanced epithelial
ovarian, fallopian tube, or primary peritoneal cancer
who are in a complete or partial response to first-line
platinum-based chemotherapy. Source: FDA website
|
Expanded Indication | 04-29-20 |
Milprosa
The Food and Drug Administration (FDA)
approved MilprosaTM (progesterone vaginal system) to
support embryo implantation and early pregnancy (up to
10 weeks post-embryo transfer) by supplementation of
corpus luteal function as part of an Assisted
Reproductive Technology treatment program for infertile
women up to and including 34 years of age. Source: FDA
website
|
New Formulation | 04-29-20 |
Darzalex Faspro
The Food and Drug Administration (FDA)
approved Darzalex FasproTM
(daratumumab/hyaluronidase-fihj subcutaneous injection)
for adults with newly diagnosed or relapsed/refractory
multiple myeloma. Source: FDA website
|
New Formulation | 05-01-20 |
Fensolvi
The Food and Drug Administration (FDA)
approved Fensolvi® (leuprolide acetate sustained release
subcutaneous injection) for the treatment of pediatric
individuals 2 years of age and older with central
precocious puberty. Source: FDA website
|
New Formulation | 05-01-20 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) to reduce the
risk of cardiovascular (CV) death and hospitalization
for heart failure in adults with heart failure (NYHA
class II-IV) with reduced ejection fraction (HFrEF) with
and without type 2 diabetes (T2D). Source: FDA website
|
New Indication | 05-05-20 |
Elyxyb
The Food and Drug Administration (FDA)
approved Elyxyb (celecoxib oral solution) for acute
treatment of migraine with or without aura in adults.
Source: FDA website
|
New Formulation | 05-05-20 |
Tabrecta
The Food and Drug Administration (FDA)
approved TabrectaTM (capmatinib tablets) for the
treatment of adults with metastatic non-small cell lung
cancer (NSCLC) whose tumors have a mutation that leads
to mesenchymal-epithelial transition (MET) exon 14
skipping as detected by an FDA-approved test. Source:
FDA website
|
New Formulation | 05-06-20 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) for first-line
maintenance treatment with bevacizumab for homologous
recombination deficiency (HRD)-positive advanced ovarian
cancer. Source: FDA website
|
Expanded Indication | 05-08-20 |
Retevmo
The Food and Drug Administration (FDA)
approved RetevmoTM (selpercatinib capsules) for adults
with metastatic rearranged during transfection (RET)
fusion-positive non-small cell lung cancer (NSCLC),
adult and pediatric individuals 12 years of age and
older with advanced or metastatic RET-mutant medullary
thyroid cancer (MTC) who require systemic therapy, and
for adult and pediatric individuals 12 years of age and
older with advanced or metastatic RET fusion-positive
thyroid cancer who require systemic therapy and who are
radioactive iodine-refractory (if radioactive iodine is
appropriate). Source: FDA website
|
New Drug | 05-08-20 |
Lactated Ringer's
ICU Medical announced a voluntary
recall of one lot of Lactated Ringer’s injection due to
the presence of particulate matter identified as iron
oxide. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-due-presence
Source: FDA website
|
Drug Recall | 05-08-20 |
Finasteride Plus
MasterPharm announced a voluntary
recall of one lot of Finasteride Plus 1.25 mg capsules
due to presence of undeclared antihypertensive drug
minoxidil. Finasteride Plus is a compounded drug for
hair loss. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared
Source: FDA website
|
Drug Recall | 05-12-20 |
Pomalyst
The Food and Drug Administration (FDA)
approved Pomalyst® (pomalidomide capsules) for treating
adults with acquired immunodeficiency syndrome
(AIDS)-related Kaposi sarcoma after failure of highly
active antiretroviral therapy and Kaposi sarcoma in
adults who are human immunodeficiency virus
(HIV)-negative. Source: FDA website
|
New Indication | 05-14-20 |
Rubraca
The Food and Drug Administration (FDA)
approved Rubraca® (rucaparib tablets) for the treatment
of adults with a deleterious BRCA mutation (germline
and/or somatic)-associated metastatic
castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and
a taxane-based chemotherapy. Source: FDA website
|
New Indication | 05-15-20 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) and Yervoy®
(ipilimumab injection) as first-line treatment for
individuals with metastatic non-small cell lung cancer
(NSCLC) whose tumors express programmed cell death
ligand 1 (PD-L1) (≥1%), as determined by an FDA-approved
test, with no epidermal growth factor receptor (EGFR) or
anaplastic lymphoma kinase (ALK) genomic tumor
aberrations. Source: FDA website
|
Expanded Indication | 05-15-20 |
Tecentriq
The Food and Drug Administration (FDA)
approved Tecentriq® (atezolizumab injection) for the
first-line treatment of adults with metastatic non-small
cell lung cancer (NSCLC) whose tumors have high
programmed cell death ligand 1 (PD-L1) expression (PD-L1
stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained
tumor-infiltrating immune cells [IC] covering ≥ 10% of
the tumor area [IC ≥ 10%]), with no epidermal growth
factor receptor (EGFR) or anaplastic lymphoma kinase
(ALK) genomic tumor aberrations. Source: FDA website
|
New Indication | 05-18-20 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) for adults with
deleterious or suspected deleterious germline or somatic
homologous recombination repair (HRR) gene-mutated
metastatic castration-resistant prostate cancer (mCRPC),
who have progressed following prior treatment with
enzalutamide or abiraterone. Source: FDA website
|
New Indication | 05-19-20 |
Alunbrig
The Food and Drug Administration (FDA)
approved Alunbrig® (brigatinib tablets) for adults with
anaplastic lymphoma kinase (ALK)-positive metastatic
non-small cell lung cancer (NSCLC) as detected by an
FDA-approved test. Source: FDA website
|
New Indication | 05-22-20 |
Opdivo and Yervoy
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) plus Yervoy®
(ipilimumab injection) given with two cycles of
platinum-doublet chemotherapy for the first-line
treatment of adults with metastatic or recurrent
non-small cell lung cancer (NSCLC) with no epidermal
growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) genomic tumor aberrations. Source: FDA
website
|
New Indication | 05-26-20 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection) for children
aged 6 to 11 years with moderate-to-severe atopic
dermatitis whose disease is not adequately controlled
with topical prescription therapies or when those
therapies are not considered suitable. Source: FDA
website
|
Expanded Indication | 05-26-20 |
Zosyn
The Food and Drug Administration (FDA)
approved Zosyn® (piperacillin/tazobactam injection) for
the treatment of nosocomial pneumonia in individuals 2
months and older. Source: FDA website
|
Expanded Indication | 05-26-20 |
Kynmobi
The Food and Drug Administration (FDA)
approved KynmobiTM (apomorphine sublingual film) for the
acute, intermittent treatment of OFF episodes in
individuals with Parkinson’s disease. Source: FDA
website
|
New Formulation | 05-22-20 |
Ferriprox
The Food and Drug Administration (FDA)
approved Ferriprox® (deferiprone tablets) for the
treatment of transfusional iron overload due to
thalassemia syndromes when current chelation therapy is
inadequate. There are 2 new 1,000 mg tablet formulations
with different dosage frequencies (twice daily and three
times daily). Source: FDA website
|
New Formulation | 05-22-20 |
Artesunate
The Food and Drug Administration (FDA)
approved Artesunate injection to treat severe malaria in
adult and pediatric individuals. Source: FDA website
|
New Formulation | 05-26-20 |
VESIcare LS
The Food and Drug Administration (FDA)
approved VESIcare LSTM (solifenacin oral suspension) for
the treatment of neurogenic detrusor overactivity (NDO),
a form of bladder dysfunction related to neurological
impairment, in children ages two years and older.
Source: FDA website
|
New Formulation | 05-26-20 |
Impeklo
The Food and Drug Administration (FDA)
approved ImpekloTM (clobetasol propionate topical lotion
for the relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses
in individuals 18 years of age and older. Source: FDA
website
|
New Formulation | 05-19-20 |
Sirturo
The Food and Drug Administration (FDA)
approved Sirturo® (bedaquiline 20 mg tablets) for the
treatment of pulmonary multi-drug resistant tuberculosis
as part of combination therapy in individuals 5 to 12
years of age and weighing at least 15 kg. Source: FDA
website
|
New Formulation | 05-27-20 |
Phexxi
The Food and Drug Administration (FDA)
approved PhexxiTM (lactic acid/citric acid/potassium
bitartrate vaginal gel for the prevention of pregnancy
in females of reproductive potential for use as an
on-demand method of contraception. Source: FDA website
|
New Formulation | 05-22-20 |
Qinlock
The Food and Drug Administration (FDA)
approved QinlockTM (ripretinib tablets) the treatment of
adults with advanced gastrointestinal stromal tumor
(GIST) who have received prior treatment with 3 or more
kinase inhibitors, including imatinib. Source: FDA
website
|
New Drug | 05-15-20 |
NP Thyroid
Acella Pharmaceuticals announced a
voluntary recall of certain lots of NP Thyroid tablets
due to super potency. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid
Source: FDA website
|
Drug Recall | 05-22-20 |
Metformin Hydrochloride Extended-Release
Apotex announced a voluntary recall of
all lots of metformin hydrochloride extended-release 500
mg tablets after one lot was tested by the Food and Drug
Administration (FDA) and showed N-Nitrosodimethylamine
(NDMA) concentrations exceeding established levels.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets
Source: FDA website
|
Drug Recall | 05-29-20 |
Brilinta
The Food and Drug Administration (FDA)
approved Brilinta® (ticagrelor tablets) to reduce the
risk of a first myocardial infarction (MI) or stroke in
individuals with coronary artery disease (CAD) at high
risk for such events. Source: FDA website
|
New Indication | 05-28-20 |
Tecentriq
The Food and Drug Administration (FDA)
approved Tecentriq® (atezolizumab injection) plus
bevacizumab to treat individuals with unresectable or
metastatic hepatocellular carcinoma (HCC) who have not
received prior systemic therapy. Source: FDA website
|
New Indication | 05-29-20 |
Cyramza
The Food and Drug Administration (FDA)
approved Cyramza® (ramucirumab injection) in combination
with erlotinib for first-line treatment of metastatic
non-small cell lung cancer (NSCLC) with epidermal growth
factor receptor (EGFR) exon 19 deletions or exon 21
(L858R) mutations. Source: FDA website
|
New Indication | 05-29-20 |
Taltz
The Food and Drug Administration (FDA)
approved Taltz® (ixekizumab injection for the treatment
of active non-radiographic axial spondyloarthritis
(nr-axSpA) in individuals with objective signs of
inflammation. Source: FDA website
|
New Indication | 05-29-20 |
Zilxi
The Food and Drug Administration (FDA)
approved ZilxiTM (minocycline topical foam) for the
treatment of inflammatory lesions of rosacea in adults.
Source: FDA website
|
New Formulation | 05-28-20 |
Akynzeo
The Food and Drug Administration (FDA)
approved Akynzeo® (fosnetupitant/palonosetron
ready-to-dilute injection) for the prevention of acute
and delayed nausea and vomiting associated with initial
and repeat courses of highly emetogenic cancer
chemotherapy in adults, when given with dexamethasone.
Source: FDA website
|
New Formulation | 06-02-20 |
Oriahnn
The Food and Drug Administration (FDA)
approved Oriahnn® (elagolix/estradiol/norethindrone
acetate co-packaged capsules) for the management of
heavy menstrual bleeding associated with uterine
fibroids in premenopausal women. Source: FDA website
|
New Formulation | 05-29-20 |
Orladeyo
The Food and Drug Administration (FDA)
approved Orladeyo™ (berotralstat capsule) as
prophylaxis to prevent attacks of hereditary angioedema
(HAE) in individuals 12 years and older. Source: FDA
website
|
New Drug | 12-03-20 |
Amneal
Amneal announced a voluntary recall of
all lots of metformin hydrochloride extended-release
tablets 500 and 750 mg after seven lots were tested by
the Food and Drug Administration (FDA) and showed
N-Nitrosodimethylamine (NDMA) concentrations exceeding
established levels. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA website
|
Drug Recall | 06-02-20 |
Apotex
Apotex announced a voluntary recall of
all lots of metformin hydrochloride extended-release 500
mg tablets after one lot was tested by the Food and Drug
Administration (FDA) and showed N-Nitrosodimethylamine
(NDMA) concentrations exceeding established levels.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets
Source: FDA website
|
Drug Recall | 05-28-20 |
Epinephrine auto-injectors
The Food and Drug Administration (FDA)
alerted consumers, caregivers, and health care providers
to immediately inspect certain lots of Amneal and Impax
epinephrine auto-injectors 0.3 mg to ensure the yellow
“stop collar” in the device is present. If the
auto-injector is missing the yellow “stop collar”
component, the device has the potential safety risk of
delivering a double dose of epinephrine. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/medical-product-safety-information/epinephrine-auto-injector-devices-amneal-and-impax-cder-alert-fda-alerts-patients-and-health-care
Source: FDA website
|
Drug Warning | 06-01-20 |
Recarbrio
The Food and Drug Administration (FDA)
approved RecarbrioTM (imipenem/cilastatin/relebactam
injection) to treat hospital-acquired bacterial
pneumonia and ventilator-associated bacterial pneumonia
(HABP/VABP) in individuals 18 years of age and older.
Source: FDA website
|
New Indication | 06-04-20 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) for individuals
with unresectable advanced, recurrent or metastatic
esophageal squamous cell carcinoma (ESCC) after prior
fluoropyrimidine- and platinum-based chemotherapy.
Source: FDA website
|
New Indication | 06-10-20 |
Semglee
The Food and Drug Administration (FDA)
approved SemgleeTM (insulin glargine injection) to
control high blood sugar in adults with type 2 diabetes
and adult and pediatric individuals with type 1
diabetes. Source: FDA website
|
New Formulation | 06-11-20 |
Uplizna
The Food and Drug Administration (FDA)
approved UpliznaTM (inebilizumab-cdon injection) for the
treatment of neuromyelitis optica spectrum disorder
(NMOSD) in adults with a particular antibody
(individuals who are anti-aquaporin-4 or AQP4 antibody
positive). Source: FDA website
|
New Drug | 06-11-20 |
Teva
Teva announced a voluntary recall of
fourteen lots of metformin hydrochloride
extended-release 500 and 750 mg tablets due to the
detection of N-Nitrosodimethylamine (NDMA)
concentrations in excess of established levels. Contact
your health care provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-initiates-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA website
|
Drug Recall | 06-05-20 |
Marksans Pharma
Marksans Pharma announced a voluntary
recall of one lot of metformin hydrochloride
extended-release 500 mg tablets after a Food and Drug
Administration (FDA) analysis found the product to
contain N-Nitrosodimethylamine (NDMA) concentrations
exceeding established levels. Contact your health care
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release
Source: FDA website
|
Drug Recall | 06-05-20 |
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a
voluntary recall of one lot of metformin hydrochloride
extended-release 500 mg tablets after a Food and Drug
Administration (FDA) analysis found the product to
contain N-Nitrosodimethylamine (NDMA) concentrations
exceeding established levels. Contact your health care
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-one-lot-metformin-hydrochloride
Source: FDA website
|
Drug Recall | 06-11-20 |
Gardasil 9
The Food and Drug Administration (FDA)
approved Gardasil® 9 (human papillomavirus 9-valent
vaccine injection) for the prevention of oropharyngeal
and other head and neck cancers caused by human
papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and
58. Source: FDA website
|
New Indication | 06-12-20 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) as
monotherapy for the treatment of adult and pediatric
individuals with unresectable or metastatic tumor
mutational burden-high (TMB-H) [≥10 mutations/megabase
(mut/Mb)] solid tumors, as determined by a Food and Drug
Administration (FDA)-approved test, that have progressed
following prior treatment and who have no satisfactory
alternative treatment options. Source: FDA website
|
New Indication | 06-16-20 |
Ilaris
The Food and Drug Administration (FDA)
approved Ilaris® (canakinumab injection) for the
treatment of Active Still’s disease, including
Adult-Onset Still’s Disease (AOSD). Source: FDA website
|
New Indication | 06-16-20 |
Cosentyx
The Food and Drug Administration (FDA)
approved Cosentyx® (secukinumab injection) for the
treatment of active non-radiographic axial
spondyloarthritis. Source: FDA website
|
New Indication | 06-16-20 |
Crysvita
The Food and Drug Administration (FDA)
approved Crysvita® (burosumab-twza injection) to treat
individuals aged 2 years and older with tumor-induced
osteomalacia (TIO). Source: FDA website
|
New Indication | 06-18-20 |
Tazverik
The Food and Drug Administration (FDA)
approved TazverikTM (tazemetostat tablets) for adults
with relapsed or refractory follicular lymphoma whose
tumors are positive for an enhancer of zeste homolog 2
(EZH2) mutation as detected by an FDA-approved test and
who have received at least 2 prior systemic therapies,
and for adults with relapsed or refractory follicular
lymphoma who have no satisfactory alternative treatment
options. Source: FDA website
|
New Indication | 06-18-20 |
Erelzi
The Food and Drug Administration (FDA)
approved ErelziTM (etanercept-szzs injection) for the
treatment of individuals ages 4 to 17 years with chronic
moderate to severe plaque psoriasis who are candidates
for systemic therapy or phototherapy. Source: FDA
website
|
Expanded Indication | 06-11-20 |
Mylotarg
The Food and Drug Administration (FDA)
approved MylotargTM (gemtuzumab ozogamicin injection)
for newly diagnosed CD33-positive acute myeloid leukemia
(AML) to include pediatric individuals 1 month and
older. Source: FDA website
|
Expanded Indication | 06-16-20 |
Tivicay
The Food and Drug Administration (FDA)
approved Tivicay® (dolutegravir tablets) to treat human
immunodeficiency virus 1 (HIV)-1 infection in pediatric
individuals at least four weeks old and weighing at
least 3 kg (6.61 pounds) in combination with other
antiretroviral treatments. Source: FDA website
|
Expanded Indication | 06-12-20 |
Tivicay PD
The Food and Drug Administration (FDA)
approved Tivicay® PD (dolutegravir tablets for
suspension) to treat human immunodeficiency virus 1
(HIV)-1 infection in pediatric individuals at least four
weeks old and weighing at least 3 kg (6.61 pounds) in
combination with other antiretroviral treatments.
Source: FDA website
|
New Formulation | 06-12-20 |
Lyumjev
The Food and Drug Administration (FDA)
approved LyumjevTM (insulin lispro-aabc rapid-acting
injection) to improve glycemic control in adults with
type 1 and type 2 diabetes. Source: FDA website
|
New Formulation | 06-15-20 |
Zepzelca
The Food and Drug Administration (FDA)
approved ZepzelcaTM (lurbinectedin injection) for the
treatment of adults with metastatic small cell lung
cancer (SCLC) with disease progression on or after
platinum-based chemotherapy. Source: FDA website
|
New Drug | 06-15-20 |
Lorbrena
The Food and Drug Administration (FDA)
approved Lorbrena® (lorlatinib tablets) for first-line
treatment of individuals with anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC).
Source: FDA website
|
New Indication | 03-03-21 |
Actemra
The Food and Drug Administration (FDA)
approved Actemra® (tocilizumab subcutaneous injection)
for slowing the rate of decline in pulmonary function in
adults with systemic sclerosis-associated interstitial
lung disease (SSc-ILD). Source: FDA website
|
New Indication | 03-04-21 |
Yescarta
The Food and Drug Administration (FDA)
approved Yescarta® (axicabtagene ciloleucel injection)
for the treatment of adults with relapsed or refractory
follicular lymphoma (FL) after two or more lines of
systemic therapy. Source: FDA website
|
New Indication | 03-05-21 |
Flucelvax Quadrivalent
The Food and Drug Administration (FDA)
approved Flucelvax® Quadrivalent (inactivated influenza
vaccine injection) for active immunization in
individuals 2 years of age and older against influenza
disease caused by influenza virus subtypes A and type B
contained in the vaccine. Source: FDA website
|
New Indication | 03-05-21 |
Azstarys
The Food and Drug Administration (FDA)
approved AzstarysTM
(serdexmethylphenidate/dexmethylphenidate capsules) for
the treatment of attention deficit hyperactivity
disorder (ADHD) in individuals age six years and older.
Source: FDA website
|
New Drug | 03-02-21 |
Fotivda
The Food and Drug Administration (FDA)
approved Fotivda® (tivozanib capsules) for the treatment
of adults with relapsed or refractory advanced renal
cell carcinoma (RCC) following two or more prior
systemic therapies. Source: FDA website
|
New Drug | 03-10-21 |
Spironolactone
Bryant Ranch Prepack announced a
voluntary recall of 4 lots of spironolactone tablets due
to mislabeling with the incorrect strength. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due
Source: FDA website
|
Drug Recall | 03-10-21 |
Remdesivir
The Food and Drug Administration (FDA)
is warning health care providers that co-administration
of remdesivir and chloroquine phosphate or
hydroxychloroquine sulfate is not recommended as it may
result in reduced antiviral activity of remdesivir.
Contact your health care provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/remdesivir-gilead-sciences-fda-warns-newly-discovered-potential-drug-interaction-may-reduce
Source: FDA website
|
Drug Warning | 06-15-20 |
Xpovio
The Food and Drug Administration (FDA)
approved Xpovio® (selinexor tablets) for the treatment
of adults with relapsed or refractory diffuse large
B-cell lymphoma (DLBCL), not otherwise specified,
including DLBCL arising from follicular lymphoma, after
at least two lines of systemic therapy. Source: FDA
website
|
New Indication | 06-22-20 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) for
individuals with recurrent or metastatic cutaneous
squamous cell carcinoma (cSCC) that is not curable by
surgery or radiation. Source: FDA website
|
New Indication | 06-24-20 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) the
first-line treatment of individuals with unresectable or
metastatic microsatellite instability-high (MSI-H) or
mismatch repair deficient (dMMR) colorectal cancer.
Source: FDA website
|
New Indication | 06-29-20 |
Bavencio
The Food and Drug Administration (FDA)
approved Bavencio® (avelumab injection) for first-line
maintenance treatment in individuals with locally
advanced or metastatic urothelial carcinoma. Source: FDA
website
|
New Indication | 06-30-20 |
Lialda
The Food and Drug Administration (FDA)
approved Lialda® (mesalamine tablets) for the treatment
of mildly to moderately active ulcerative colitis in
pediatric individuals weighing at least 24 kg. Source:
FDA website
|
Expanded Indication | 06-26-20 |
Sivextro
The Food and Drug Administration (FDA)
approved Sivextro® (tedizolid injection and tablets) for
the treatment of acute bacterial skin and skin structure
infections (ABSSSI) in pediatric individuals from 12
years to less than 18 years of age. Source: FDA website
|
Expanded Indication | 06-19-20 |
Gimoti
The Food and Drug Administration (FDA)
approved GimotiTM (metoclopramide nasal spray) for the
relief of symptoms in adults with acute and recurrent
diabetic gastroparesis. Source: FDA website
|
New Formulation | 06-19-20 |
Mycapssa
The Food and Drug Administration (FDA)
approved Mycapssa® (octreotide capsules) for the
long-term maintenance treatment of individuals with
acromegaly who have responded to and tolerated
octreotide or lanreotide. Source: FDA website
|
New Formulation | 06-26-20 |
Fintepla
The Food and Drug Administration (FDA)
approved Fintepla® (fenfluramine oral solution) for the
treatment of Dravet syndrome in individuals 2 years of
age and older. Source: FDA website
|
New Formulation | 06-26-20 |
Phesgo
The Food and Drug Administration (FDA)
approved PhesgoTM
(pertuzumab/trastuzumab/hyaluronidase-zzxf subcutaneous
injection) for use in combination with chemotherapy as
neoadjuvant treatment of individuals with human
epidermal growth factor receptor 2 (HER2)-positive,
locally advanced, inflammatory, or early stage breast
cancer as part of a complete treatment regimen for early
breast cancer or as adjuvant treatment of individuals
with HER2-positive early breast cancer at high risk of
recurrence. Also approved for use in combination with
docetaxel for treatment of individuals with HER2-
positive metastatic breast cancer who have not received
prior anti-HER2 therapy or chemotherapy for metastatic
disease. Source: FDA website
|
New Formulation | 06-29-20 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection) pre-filled pen
formulation for all indications in individuals aged 12
years and older, which includes use in certain
individuals with atopic dermatitis, asthma and chronic
rhinosinusitis with nasal polyposis (CRSwNP), for
at-home administration. Source: FDA website
|
New Formulation | 06-19-20 |
Dojolvi
The Food and Drug Administration (FDA)
approved DojolviTM (triheptanoin oral liquid) as a
source of calories and fatty acids for the treatment of
pediatric and adult individuals with molecularly
confirmed long-chain fatty acid oxidation disorders
(LC-FAOD). Source: FDA website
|
New Drug | 06-30-20 |
Botox
The Food and Drug Administration (FDA)
approved Botox® (onabotulinumtoxinA injection) for the
treatment of spasticity in pediatric individuals 2 years
of age and older, including those with lower limb
spasticity caused by cerebral palsy. Source: FDA website
|
Expanded Indication | 07-08-20 |
Dysport
The Food and Drug Administration (FDA)
approved Dysport® (abobotulinumtoxinA injection) for the
treatment of spasticity in pediatric individuals 2 years
of age and older, including those with upper and lower
limb spasticity caused by cerebral palsy. Source: FDA
website
|
Expanded Indication | 07-08-20 |
Tremfya
The Food and Drug Administration (FDA)
approved Tremfya® (guselkumab injection) for the
treatment of adults with active psoriatic arthritis.
Source: FDA website
|
New Indication | 07-13-20 |
Tralement
The Food and Drug Administration (FDA)
approved TralementTM (trace elements injection) in adult
and pediatric individuals weighing at least 10 kg as a
source of zinc, copper, manganese, and selenium for
parenteral nutrition when oral or enteral nutrition is
not possible, insufficient, or contraindicated. Source:
FDA website
|
New Formulation | 07-02-20 |
Qwo
The Food and Drug Administration (FDA)
approved QwoTM (collagenase clostridium
histolyticum-aaes injection) for the treatment of
moderate to severe cellulite in the buttocks of adult
women. Source: FDA website
|
New Formulation | |
Upneeq
The Food and Drug Administration (FDA)
approved UpneeqTM (oxymetazoline hydrochloride
ophthalmic solution) for the treatment of acquired
blepharoptosis (droopy eyelid) in adults. Source: FDA
website
|
New Formulation | 07-08-20 |
Inqovi
The Food and Drug Administration (FDA)
approved Inqovi® (decitabine/cedazuridine injection) for
the treatment of adults with certain myelodysplastic
syndromes (MDS). Source: FDA website
|
New Drug | 07-07-20 |
Byfavo
The Food and Drug Administration (FDA)
approved ByfavoTM (remimazolam injection) for the
induction and maintenance of procedural sedation in
adults undergoing procedures lasting 30 minutes or less.
Source: FDA website
|
New Drug | 07-02-20 |
Rukobia
The Food and Drug Administration (FDA)
approved Rukobia (fostemsavir extended-release tablets)
in combination with other antiretroviral(s), for the
treatment of human immunodeficiency virus (HIV)-1
infection in heavily treatment-experienced adults with
multidrug-resistant HIV-1 infection failing their
current antiretroviral regimen due to resistance,
intolerance, or safety considerations. Source: FDA
website
|
New Drug | 07-02-20 |
Daptomycin
Mylan announced a voluntary recall of
one lot of daptomycin for injection 500 mg/vial due to
the presence of particulate matter. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-one-lot-daptomycin-injection-due-presence-particulate
Source: FDA website
|
Drug Recall | 07-07-20 |
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a
voluntary recall of all batches of metformin
hydrochloride extended-release 500 mg and 1000 mg
tablets due to certain batches exceeding the acceptable
limit for the impurity N-Nitrosodimethylamine (NDMA).
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended
Source: FDA website
|
Drug Recall | 07-08-20 |
Granules Pharmaceuticals
Granules Pharmaceuticals announced a
voluntary recall of twelve lots of metformin
hydrochloride extended-release 750 mg tablets due to the
detection of N-Nitrosodimethylamine (NDMA) levels above
the acceptable limit. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA website
|
Drug Recall | 07-06-20 |
Metformin Extended-Release
The Food and Drug Administration (FDA)
is alerting consumers and health care providers to
several voluntary recalls of extended release metformin
by certain companies. The companies are recalling
metformin due to the possibility they could contain
nitrosodimethylamine (NDMA) above the acceptable intake
limit. Contact your healthcare provider with questions.
More details and a list of companies may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_campaign=Several%20Companies%20Voluntarily%20Recall%20Extended%20Release%20Metformin&utm_medium=email&utm_source=Eloqua
Source: FDA website
|
Drug Recall | 07-13-20 |
Qutenza
The Food and Drug Administration (FDA)
approved Qutenza® (capsaicin topical patch) for the
treatment of neuropathic pain associated with diabetic
peripheral neuropathy (DPN) of the feet. Source: FDA
website
|
New Indication | 07-17-20 |
Wynzora
The Food and Drug Administration (FDA)
approved Wynzora® (calcipotriene/betamethasone
dipropionate topical cream) for once daily treatment of
plaque psoriasis in adults 18 years of age or older.
Source: FDA website
|
New Formulation | 07-20-20 |
Xywav
The Food and Drug Administration (FDA)
approved XywavTM (calcium/magnesium/potassium/sodium
oxybates oral solution) for cataplexy or excessive
daytime sleepiness associated with narcolepsy. Xywav
contains 92% less sodium per dose than currently
available sodium oxybate formulation. Source: FDA
website
|
New Formulation | 07-21-20 |
Breztri Aerosphere
The Food and Drug Administration (FDA)
approved Breztri AerosphereTM
(budesonide/glycopyrrolate/formoterol fumarate oral
inhalation) for the maintenance treatment of individuals
with chronic obstructive pulmonary disease (COPD).
Source: FDA website
|
New Formulation | 07-23-20 |
Xeglyze
The Food and Drug Administration (FDA)
approved XeglyzeTM (abametapir topical lotion) for the
treatment of head lice infestation in individuals 6
months of age and older. Source: FDA website
|
New Drug | 07-24-20 |
Tecartus
The Food and Drug Administration (FDA)
approved TecartusTM (brexucabtagene autoleucel
intravenous infusion) for the treatment of adults with
relapsed or refractory mantle cell lymphoma (MCL).
Source: FDA website
|
New Drug | 07-24-20 |
Dexmedetomidine hydrochloride
Fresenius Kabi announced a voluntary
recall of two lots of dexmedetomidine hydrochloride
injection due to the possible presence of trace amounts
of lidocaine. Contact your health care provider with
questions More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hydrochloride-injection
Source: FDA website
|
Drug Recall | 07-23-20 |
Opioid pain relievers and drugs to treat
opioid use disorder
The Food and Drug Administration (FDA)
is requiring drug manufacturers for all opioid pain
relievers and drugs to treat opioid use disorder to add
new recommendations about naloxone to the prescribing
information. Contact your health care provider with
questions More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/opioid-pain-relievers-or-medicines-treat-opioid-use-disorder-medwatch-safety-alert-fda-recommends
Source: FDA website
|
Drug Warning | 07-23-20 |
Stelara
The Food and Drug Administration (FDA)
approved Stelara® (ustekinumab injection) for the
treatment of pediatric individuals 6 to 11 years of age
with moderate to severe plaque psoriasis. Source: FDA
website
|
New Indication | 07-29-20 |
Tecentriq
The Food and Drug Administration (FDA)
approved Tecentriq® (atezolizumab injection) in
combination with Cotellic® (cobimetinib tablets) and
Zelboraf® (vemurafenib tablets) for the treatment of
BRAF V600 mutation-positive advanced melanoma. Source:
FDA website
|
New Indication | 07-30-20 |
Epidiolex
The Food and Drug Administration (FDA)
approved Epidiolex® (cannabidiol oral solution) for the
treatment of seizures associated with tuberous sclerosis
complex (TSC) in individuals one year of age and older.
Source: FDA website
|
New Indication | 07-31-20 |
Spravato
The Food and Drug Administration (FDA)
approved Spravato® (esketamine nasal spray) with an oral
antidepressant to treat depressive symptoms in adults
with major depressive disorder (MDD) with acute suicidal
ideation or behavior. Source: FDA website
|
Expanded Indication | 07-31-20 |
Prezcobix
The Food and Drug Administration (FDA)
approved Prezcobix® (cobicistat/darunavir tablets) for
use in combination with other antiretroviral agents for
the treatment of human immunodeficiency virus 1 (HIV-1)
infection in treatment naïve and treatment-experienced
pediatric individuals weighing at least 40 kg with no
darunavir resistance-associated substitutions. Source:
FDA website
|
Expanded Indication | 07-31-20 |
Evotaz
The Food and Drug Administration (FDA)
approved Evotaz® (atazanavir sulfate/cobicistat tablets)
for use in combination with other antiretroviral agents
for the treatment of human immunodeficiency virus 1
(HIV-1) infection in pediatric individuals weighing at
least 35 kg. Source: FDA website
|
Expanded Indication | 07-31-20 |
Suprep
The Food and Drug Administration (FDA)
approved Suprep® (sodium sulfate/potassium
sulfate/magnesium sulfate oral solution) for cleansing
of the colon in preparation for colonoscopy in pediatric
individuals 12 years of age and older. Source: FDA
website
|
Expanded Indication | 08-05-20 |
Dovato
The Food and Drug Administration (FDA)
approved Dovato (dolutegravir/lamivudine tablets) for
the treatment of human immunodeficiency virus 1 (HIV-1)
infection in individuals who are virologically
suppressed on a stable antiretroviral regimen with no
history of treatment failure. Source: FDA website
|
Expanded Indication | 08-06-20 |
Xtandi
The Food and Drug Administration (FDA)
approved Xtandi® (enzalutamide tablets) for the
treatment of individuals with castration-resistant
prostate cancer or metastatic castration-sensitive
prostate cancer. Source: FDA website
|
New Formulation | 08-04-20 |
Monjuvi
The Food and Drug Administration (FDA)
approved Monjuvi® (tafasitamab-cxix injection) in
combination with lenalidomide for the treatment of
adults with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL) not otherwise specified, including
DLBCL arising from low grade lymphoma, and who are not
eligible for autologous stem cell transplant (ASCT).
Source: FDA website
|
New Drug | 07-31-20 |
Blenrep
The Food and Drug Administration (FDA)
approved Blenrep (belantamab mafodotin-blmf injection)
for adults with relapsed or refractory multiple myeloma
who have received at least 4 prior therapies, including
an anti-CD38 monoclonal antibody, a proteasome
inhibitor, and an immunomodulatory agent. Source: FDA
website
|
New Drug | 08-05-20 |
Lampit
The Food and Drug Administration (FDA)
approved Lampit® (nifurtimox tablets) for the treatment
of Chagas disease in children. Source: FDA website
|
New Drug | 08-06-20 |
Evrysdi
The Food and Drug Administration (FDA)
approved EvrysdiTM (risdiplam oral solution) for the
treatment of spinal muscular atrophy (SMA) in
individuals 2 months of age and older. Source: FDA
website
|
New Drug | 08-07-20 |
DDAVP, Desmopressin Acetate, and Stimate
Ferring Pharmaceuticals announced a
voluntary recall of all lots of DDAVP® (desmopressin
nasal spray) 10 mcg/0.1 mL, Desmopressin Acetate nasal
spray 10 mcg/0.1 mL, and Stimate® (desmopressin nasal
spray) 1.5 mg/mL. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate
Source: FDA website
|
Drug Recall | 08-06-20 |
Darzalex
The Food and Drug Administration (FDA)
approved Darzalex® (daratumumab injection) in
combination with Kyprolis® (carfilzomib injection) and
dexamethasone for the treatment of adults with
relapsed/refractory multiple myeloma who have received
one to three previous lines of therapy. Source: FDA
website
|
Expanded Indication | 08-20-20 |
Xyntha
The Food and Drug Administration (FDA)
approved Xyntha® (antihemophilic factor, recombinant
injection) for routine prophylaxis to reduce the
frequency of bleeding episodes in individuals with
hemophilia A. Source: FDA website
|
New Indication | 07-29-20 |
Xeomin
The Food and Drug Administration (FDA)
approved Xeomin® (incobotulinumtoxinA injection) for the
treatment of individuals 2 years and older with upper
limb spasticity, excluding spasticity caused by cerebral
palsy. Source: FDA website
|
New Indication | 08-19-20 |
Cystadrops
The Food and Drug Administration (FDA)
approved Cystadrops® (cysteamine ophthalmic solution)
for the treatment of corneal cystine crystal deposits in
adults and children with cystinosis. Source: FDA website
|
New Formulation | 08-19-20 |
Olinvyk
The Food and Drug Administration (FDA)
approved OlinvykTM (oliceridine injection) for the
management of acute pain severe enough to require
intravenous opioid analgesic and for whom alternatives
are inadequate in adults. Source: FDA website
|
New Drug | 08-07-20 |
Viltepso
The Food and Drug Administration (FDA)
approved ViltepsoTM (viltolarsen injection) for the
treatment of Duchenne muscular dystrophy (DMD) in
individuals who have a confirmed mutation of the DMD
gene that is amenable to exon 53 skipping. Source: FDA
website
|
New Drug | 08-12-20 |
Enspryng
The Food and Drug Administration (FDA)
approved EnspryngTM (satralizumab-mwge injection) for
the treatment of neuromyelitis optica spectrum disorder
(NMOSD) in adults who are anti-aquaporin-4 (AQP4)
antibody positive. Source: FDA website
|
New Drug | 08-14-20 |
Kesimpta
The Food and Drug Administration (FDA)
approved Kesimpta® (ofatumumab injection) for the
treatment of relapsing forms of multiple sclerosis
(RMS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive disease, in adults. Source: FDA website
|
New Drug | 08-20-20 |
Bayshore Pharmaceuticals
Bayshore Pharmaceuticals announced a
voluntary recall of one lot of metformin hydrochloride
extended-release 500 mg tablets and one lot of metformin
hydrochloride extended-release 750 mg tablets due to the
detection of N-Nitrosodimethylamine (NDMA) impurity
above the acceptable daily limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA website
|
Drug Recall | 08-20-20 |
Mirena
The Food and Drug Administration (FDA)
approved Mirena® (levonorgestrel intrauterine device)
for prevention of pregnancy for up to 6 years. Source:
FDA website
|
Expanded Indication | 08-20-20 |
Ultravate
The Food and Drug Administration (FDA)
approved Ultravate® (halobetasol propionate lotion) for
the treatment of plaque psoriasis in pediatric
individuals 12 years of age and older. Source: FDA
website
|
Expanded Indication | 08-27-20 |
Onureg
The Food and Drug Administration (FDA)
approved Onureg® (azacitidine tablets) for continued
treatment of adults with acute myeloid leukemia who
achieved first complete remission (CR) or complete
remission with incomplete blood count recovery (CRi)
following intensive induction chemotherapy and are not
able to complete intensive curative therapy. Source: FDA
website
|
New Formulation | 09-01-20 |
Xaracoll
The Food and Drug Administration (FDA)
approved Xaracoll® (bupivacaine implant) for acute
postsurgical pain relief for up to 24 hours in adults
following open inguinal hernia repair. Source: FDA
website
|
New Formulation | 08-28-20 |
Sogroya
The Food and Drug Administration (FDA)
approved Sogroya® (somapacitan injection) for once
weekly treatment of adult growth hormone deficiency.
Source: FDA website
|
New Drug | 08-28-20 |
Winlevi
The Food and Drug Administration (FDA)
approved Winlevi® (clascoterone cream) for the treatment
of acne vulgaris in individuals 12 years and older.
Source: FDA website
|
New Drug | 08-26-20 |
Mylan
Mylan announced a voluntary recall of
four lots of amiodarone injection and tranexamic acid
injection due to carton label mix-up. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-four-lots-amiodarone-hcl-injection-usp-and-tranexamic
Source: FDA website
|
Drug Recall | 08-28-20 |
Invokana, Invokamet, Invokamet XR
Based on Food and Drug Administration
(FDA) review of new data from three clinical trials, the
boxed warning about amputation risk from the diabetes
medicine canagliflozin (Invokana® , Invokamet® ,
Invokamet® XR) was removed from the prescribing
information. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and
Source: FDA website
|
Drug Warning | 08-26-20 |
Trelegy Ellipta
The Food and Drug Administration (FDA)
approved Trelegy Ellipta (fluticasone
furoate/umeclidinium/vilanterol oral inhalation) for the
treatment of asthma in individuals aged 18 years and
older. Source: FDA website
|
New Indication | 09-09-20 |
Qdolo
The Food and Drug Administration (FDA)
approved QdoloTM (tramadol oral solution) for adults for
the management of pain severe enough to require an
opioid analgesic and for which alternative treatments
are inadequate. Source: FDA website
|
New Formulation | 09-01-20 |
Gavreto
The Food and Drug Administration (FDA)
approved GavretoTM (pralsetinib capsules) for the
treatment of adults with metastatic rearranged during
transfection (RET) fusion-positive non-small cell lung
cancer (NSCLC) as detected by an FDA approved test.
Source: FDA source
|
New Drug | 09-04-20 |
RLC Labs
RLC Labs announced a voluntary recall
of 483 lots of Nature-Thyroid® and WP Thyroid® (thyroid
tablets) in all strengths within current expiry due to
sub-potency. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rlc-labs-inc-issues-voluntary-nationwide-recall-all-lots-nature-throidr-and-wp-thyroidr-current
Source: FDA website
|
Drug Recall | 09-06-20 |
Tecentriq
The Food and Drug Administration (FDA)
alerted health care providers and consumers that a
clinical trial studying the use of Tecentriq®
(atezolizumab injection) and paclitaxel in individuals
with previously untreated inoperable locally advanced or
metastatic triple negative breast cancer (mTNBC) showed
the drug combination did not work to treat the disease.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-issues-alert-about-efficacy-and-potential-safety-concerns-atezolizumab-combination-paclitaxel
Source: FDA website
|
Drug Warning | 09-08-20 |
Eraxis
The Food and Drug Administration (FDA)
approved EraxisTM (anidulafungin injection) in pediatric
individuals one month and older for the treatment of
candidemia and other forms of Candida infections
(intra-abdominal abscess and peritonitis). Source: FDA
website
|
Expanded Indication | 09-22-20 |
Kalydeco
The Food and Drug Administration (FDA)
approved Kalydeco® (ivacaftor tablets and oral granules)
for use in children with cystic fibrosis (CF) ages four
months to less than six months old who have at least one
mutation in their cystic fibrosis transmembrane
conductance regulator (CFTR) gene that is responsive to
ivacaftor based on clinical and/or in vitro assay data.
Source: FDA website
|
Expanded Indication | 09-24-20 |
Acella Pharmaceuticals
Acella Pharmaceuticals announced a
voluntary recall of one lot of 15 mg and one lot of 120
mg NP Thyroid® (thyroid tablets) due to sub potency.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets
Source: FDA website
|
Drug Recall | 09-18-20 |
Albuterol
Perrigo announced a voluntary recall
of all unexpired albuterol sulfate inhalers due to
possible clogging of the inhaler. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall#:~:text=%5B9%2F21%2F2020%5D,clogging%20of%20the%20inhaler%20resulting
Source: FDA website
|
Drug Recall | 09-21-20 |
Riomet ER
Sun Pharmaceutical announced a
voluntary recall of one lot of Riomet ERTM (metformin
extended-release oral suspension) due to levels of
N-Nitrosodimethylamine (NDMA) found to be above the
allowable daily limit established by the Food and Drug
Administration (FDA). Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-issues-voluntary-nationwide-recall-riomet-ertm-metformin
Source: FDA website
|
Drug Recall | 09-23-20 |
Diphenhydramine
The Food and Drug Administration (FDA)
is warning that taking higher than recommended doses of
over-the-counter (OTC) allergy medicine diphenhydramine
can lead to serious heart problems, seizures, coma, or
death. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/benadryl-diphenhydramine-drug-safety-communication-serious-problems-high-doses-allergy-medicine
Source: FDA website
|
Drug Warning | 09-24-20 |
Dental Amalgam
The Food and Drug Administration (FDA)
is providing recommendations about the use of dental
amalgam in people who may be at greater risk to the
potential adverse effects of mercury exposure. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/medical-devices/safety-communications/recommendations-about-use-dental-amalgam-certain-high-risk-populations-fda-safety-communication
Source: FDA website
|
Drug Warning | 09-24-20 |
Benzodiazepines
The Food and Drug Administration (FDA)
is requiring an updated Boxed Warning for all
benzodiazepine medications to describe the risks of
abuse, misuse, addiction, physical dependence, and
withdrawal reactions consistently across all the
medicines in the class. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/benzodiazepine-drug-class-drug-safety-communication-boxed-warning-updated-improve-safe-use
Source: FDA website
|
Drug Warning | 09-23-20 |
Nucala
The Food and Drug Administration (FDA)
approved Nucala® (mepolizumab injection) for the
treatment of adult and pediatric individuals aged 12
years and older with hypereosinophilic syndrome (HES)
for six months or longer without an identifiable
non-hematologic secondary cause. Source: FDA website
|
New Indication | 09-25-20 |
Fetroja
The Food and Drug Administration (FDA)
approved Fetroja® (cefiderocol injection) for the
treatment of adults with hospital-acquired bacterial
pneumonia (HABP) and ventilator-associated bacterial
pneumonia (VABP) caused by susceptible Gram-negative
microorganisms. Source: FDA website
|
New Indication | 09-25-20 |
Xeljanz
The Food and Drug Administration (FDA)
approved Xeljanz® (tofacitinib tablets and oral
solution) for the treatment of children and adolescents
2 years and older with active polyarticular course
juvenile idiopathic arthritis (pcJIA). Source: FDA
website
|
New Indication | 09-25-20 |
Simponi Aria
The Food and Drug Administration (FDA)
approved Simponi Aria® (golimumab injection) for the
treatment of active polyarticular juvenile idiopathic
arthritis (pJIA) and active psoriatic arthritis (PsA).
Source: FDA website
|
New Indication | 09-29-20 |
Opdivo and Yervoy
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) and Yervoy®
(ipilimumab injection) for the treatment of previously
untreated unresectable malignant pleural mesothelioma.
Source: FDA website
|
New Indication | 10-02-20 |
Haegarda
The Food and Drug Administration (FDA)
approved Haegarda® (C1 esterase inhibitor injection) for
routine prophylaxis to prevent hereditary angioedema
(HAE) attacks in individuals 6 years of age and older.
Source: FDA website
|
Expanded Indication | 09-28-20 |
Alkindi Sprinkle
The Food and Drug Administration (FDA)
approved Alkindi® Sprinkle (hydrocortisone oral
granules) as replacement therapy for adrenocortical
insufficiency (AI) in children under 17 years of age.
Source: FDA website
|
New Formulation | 09-29-20 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) for the
treatment of adults with relapsed or refractory
classical Hodgkin lymphoma (cHL). Source: FDA website
|
Expanded Indication | 10-14-20 |
Wakix
The Food and Drug Administration (FDA)
approved Wakix® (pitolisant tablets) for the treatment
of cataplexy in adults with narcolepsy. Source: FDA
website
|
Expanded Indication | 10-13-20 |
Inmazeb
The Food and Drug Administration (FDA)
approved InmazebTM
(atoltivimab/maftivimab/odesivimab-ebgn injection) for
the treatment of infection caused by Zaire ebolavirus in
adult and pediatric individuals, including neonates born
to a mother who is RT-PCR positive for Zaire ebolavirus
infection. Source: FDA website
|
New Drug | 10-14-20 |
Marksans Pharma
Marksans Pharma announced an expanded
voluntary recall to include an additional 76 lots of
unexpired lots of metformin hydrochloride
extended-release 500 and 750 mg tablets due to levels of
N-Nitrosodimethylamine (NDMA) exceeding the acceptable
daily limit in some lots. Contact your healthcare
provider with questions. More detail may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride
Source: FDA website
|
Drug Recall | 10-05-20 |
Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs)
The Food and Drug Administration (FDA)
is warning that use of NSAIDs around 20 weeks or later
in pregnancy may cause rare but serious kidney problems
in an unborn baby. Contact your healthcare provider with
questions. More detail may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/nonsteroidal-anti-inflammatory-drugs-nsaids-drug-safety-communication-avoid-use-nsaids-pregnancy-20
Source: FDA website
|
Drug Warning | 10-15-20 |
Self-Collection of Nasal Samples
The Food and Drug Administration (FDA)
recommends that health care providers give clear,
step-by-step instructions to individuals who, in a
health care setting, are self-collecting nasal samples
for SARS-CoV-2 testing. Contact your healthcare provider
with questions. More detail may be viewed at:
https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample
Source: FDA website
|
Drug Warning | 10-13-20 |
Esomeprazole orally disintegrating tablet
The Food and Drug Administration (FDA)
approved Esomeprazole orally disintegrating
delayed-release tablets for the treatment of frequent
heartburn (occurs 2 or more days a week) in adults (18
years of age and older). Source: FDA website
|
New Formulation | 10-20-20 |
Eysuvis
The Food and Drug Administration (FDA)
approved EysuvisTM (loteprednol etabonate ophthalmic
suspension) for the short-term treatment of the signs
and symptoms of dry eye disease. Source: FDA website
|
New Formulation | 10-27-20 |
Veklury
TThe Food and Drug Administration
(FDA) approved Veklury® (remdesivir injection) for the
treatment of COVID-19 requiring hospitalization in adult
and pediatric individuals (12 years of age and older and
weighing at least 40 kg). Source: FDA website
|
New Drug | 10-22-20 |
Sklice
The Food and Drug Administration (FDA)
approved Sklice® (ivermectin topical lotion) for
over-the-counter (OTC) treatment of head lice
infestation in individuals 6 months of age and older.
Source: FDA website
|
Rx to Over-the-Counter Switch | 10-27-20 |
Selzentry
The Food and Drug Administration (FDA)
approved Selzentry® (maraviroc tablets and oral
solution) to include the treatment of human
immunodeficiency virus (HIV) infection in pediatric
individuals weighing at least 2 kg. Source: FDA website
|
New Indication | 10-30-20 |
Totect
The Food and Drug Administration (FDA)
approved Totect® (dexrazoxane injection) for reducing
the incidence and severity of cardiomyopathy associated
with doxorubicin administration in women with metastatic
breast cancer who have received a cumulative doxorubicin
dose of 300 mg/m² and who will continue to receive
doxorubicin therapy to maintain tumor control. Source:
FDA website
|
New Indication | 11-02-20 |
Brilinta
The Food and Drug Administration (FDA)
approved Brilinta® (ticagrelor tablets) to reduce the
risk of stroke in individuals with an acute ischemic
stroke or high-risk transient ischemic attack. Source:
FDA website
|
New Indication | 11-05-20 |
Bronchitol
The Food and Drug Administration (FDA)
approved Bronchitol® (mannitol inhalation powder) as
add-on maintenance therapy to improve pulmonary function
in adults 18 years of age and older with cystic fibrosis
(CF). Source: FDA website
|
New Formulation | 10-30-20 |
Metformin extended-release tablets 500 mg
Nostrum Laboratories announced a
voluntary recall of two lots of metformin
extended-release tablets 500 mg due to
N-Nitrosodimethylamine (NDMA) content above the
acceptable daily intake (ADI) limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
Source: FDA website
|
Drug Recall | 11-04-20 |
Metformin extended-release tablets 750 mg
Nostrum Laboratories announced a
voluntary recall of two lots of metformin
extended-release tablets 750 mg due to
N-Nitrosodimethylamine (NDMA) content above the
acceptable daily intake (ADI) limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets
Source: FDA website
|
Drug Recall | 11-04-20 |
Paroex
Sunstar Americas announced a voluntary
recall of Paroex® (chlorhexidine gluconate oral rinse
0.12%) due to microbial contamination. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse
Source: FDA website
|
Drug Recall | 10-28-20 |
Sutab
The Food and Drug Administration (FDA)
approved Sutab® (sodium sulfate/magnesium
sulfate/potassium chloride tablets) for colonoscopy
preparation. Source: FDA website
|
New Formulation | 10-10-20 |
Sesquient
The Food and Drug Administration (FDA)
approved SesquientTM (fosphenytoin sodium for injection)
for the treatment of status epilepticus in adult and
pediatric individuals. Source: FDA website
|
New Formulation | 11-05-20 |
Labetalol hydrochloride in dextrose
The Food and Drug Administration (FDA)
approved Labetalol hydrochloride in dextrose injection
in severe hypertension to lower blood pressure. Source:
FDA website
|
New Formulation | 11-09-20 |
Lohxa
Lohxa LLC announced a voluntary recall
of specific lots of chlorhexidine gluconate oral rinse
0.12% due to microbial contamination. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-chlorhexidine-gluconate-oral-rinse-usp-012-due
Source: FDA website
|
Drug Recall | 11-09-20 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) for use in
combination with chemotherapy to treat individuals with
locally recurrent, unresectable or metastatic
triple-negative breast cancer (TNBC) whose tumors
express PD-L1 with a combined positive score (CPS) of 10
or greater. Source: FDA website
|
New Indication | 11-13-20 |
Vimpat
The Food and Drug Administration (FDA)
approved Vimpat® (lacosamide tablet, oral solution, and
injection) as adjunctive therapy in the treatment of
primary generalized tonic-clonic seizures (PGTCS) in
individuals four years of age and older. The injection
is now also approved for the treatment of partial-onset
seizures in individuals four years of age and older.
Source: FDA website
|
New Indication | 11-16-20 |
Zokinvy
The Food and Drug Administration (FDA)
approved ZokinvyTM (lonafarnib capsule) to reduce the
risk of death due to Hutchinson-Gilford progeria
syndrome and for the treatment of certain
processing-deficient progeroid laminopathies in
individuals one year of age and older. Source: FDA
website
|
New Drug | 11-20-20 |
Dexmedetomidine hydrochloride
Fresenius Kabi announced a voluntary
recall of one lot of dexmedetomidine HCL in 0.9% sodium
chloride injection due to a trace amount of lidocaine
present in the lot. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-single-lot-dexmedetomidine-hydrochloride-injection
Source: FDA website
|
Drug Recall | 11-20-20 |
Xofluza
The Food and Drug Administration (FDA)
approved XofluzaTM (baloxavir marboxil tablets and oral
granules) for post-exposure prevention of influenza in
individuals 12 years of age and older after contact with
an individual who has the flu. A new oral granule for
mixing in water was also approved. Source: FDA website
|
New Indication and New Formulation | 11-23-20 |
Gavreto
The Food and Drug Administration (FDA)
approved GavretoTM (pralsetinib capsules) for adult and
pediatric individuals 12 years of age and older with
advanced or metastatic RET-mutant medullary thyroid
cancer (MTC) who require systemic therapy or RET
fusion-positive thyroid cancer who require systemic
therapy and who are radioactive iodine-refractory (if
radioactive iodine is appropriate). Source: FDA website
|
New Indication | 12-01-20 |
Xolair
The Food and Drug Administration (FDA)
approved Xolair® (omalizumab subcutaneous injection) as
add-on maintenance treatment of nasal polyps in adults
with inadequate response to nasal corticosteroids.
Source: FDA website
|
New Indication | 11-30-20 |
Hetlioz and Hetlioz LQ
The Food and Drug Administration (FDA)
approved Hetlioz® (tasimelteon capsules) and Hetlioz
LQTM (tasimelteon oral suspension) for the treatment of
nighttime sleep disturbances in Smith-Magenis Syndrome
(SMS) in adults and children, respectively. Source: FDA
website
|
New Indication and New Formulation | 12-01-20 |
Thyquidity
The Food and Drug Administration (FDA)
approved ThyquidityTM (levothyroxine oral solution) for
replacement therapy in hypothyroidism and as an adjunct
to surgery and radioiodine therapy in the management of
thyrotropin-dependent well-differentiated thyroid
cancer. Source: FDA website
|
New Formulation | 11-30-20 |
Oxlumo
The Food and Drug Administration (FDA)
approved OxlumoTM (lumasiran subcutaneous injection) for
the treatment of primary hyperoxaluria type 1 (PH1) to
lower urinary oxalate levels in pediatric and adult
individuals. Source: FDA website
|
New Drug | 11-23-20 |
Imcivree
The Food and Drug Administration (FDA)
approved Imcivree (setmelanotide subcutaneous injection)
for chronic
weight management in adult and pediatric individuals 6
years of age and older with obesity due to
proopiomelanocortin (POMC), proprotein convertase
subtilisin/kexin type 1 (PCSK1), or leptin receptor
(LEPR) deficiency, Source: FDA website
|
New Drug | 11-25-20 |
Danyelza
The Food and Drug Administration (FDA)
approved Danyelza® (naxitamab-gqgk intravenous
injection) for the treatment of pediatric individuals 1
year of age and older and adults with relapsed or
refractory high-risk neuroblastoma in the bone or bone
marrow who have demonstrated a partial response, minor
response, or stable disease to prior therapy. Source:
FDA website
|
New Drug | 11-25-20 |
Fusion Health and Vitality
Fusion Health and Vitality announced a
voluntary recall of all lots of Core Essential Nutrients
and Immune Boost Sublingual Vitamin D3 due to unapproved
use of a food additive. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-health-and-vitality-issues-voluntary-nationwide-recall-core-essential-nutrients-and-immune
Source: FDA website
|
Drug Recall | 11-23-20 |
Benlysta
The Food and Drug Administration (FDA)
approved Benlysta® (belimumab injection) for the
treatment of adults with active lupus nephritis who are
receiving standard therapy. Source: FDA website
|
New Indication | 12-16-20 |
Xpovio
The Food and Drug Administration (FDA)
approved Xpovio® (selinexor tablets) in combination with
bortezomib and dexamethasone for the treatment of adults
with multiple myeloma who have received at least one
prior therapy. Source: FDA website
|
New Indication | 12-18-20 |
Tagrisso
The Food and Drug Administration (FDA)
approved Tagrisso® (osimertinib tablets) in adults with
non-small cell lung cancer (NSCLC) whose tumors have
epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R mutations, as detected by a
Food and Drug Administration (FDA)-approved test.
Source: FDA website
|
New Indication | 12-18-20 |
Iclusig
The Food and Drug Administration (FDA)
approved Iclusig® (ponatinib tablets) for adults with
chronic-phase (CP) chronic myeloid leukemia (CML) with
resistance or intolerance to at least two prior kinase
inhibitors. Source: FDA website
|
New Indication | 12-18-20 |
Xeomin
The Food and Drug Administration (FDA)
approved Xeomin® (incobotulinumtoxinA injection) for the
treatment of individuals aged 2 years and older with
chronic sialorrhea, or drooling. Source: FDA website
|
New Indication | 12-18-20 |
Kineret
The Food and Drug Administration (FDA)
approved Kineret® (anakinra injection) for treatment of
deficiency of interleukin-1 receptor antagonist. Source:
FDA website
|
New Indication | 12-18-20 |
Arcalyst
The Food and Drug Administration (FDA)
approved Arcalyst® (rilonacept injection) for
maintenance of remission of deficiency of interleukin-1
receptor antagonist (DIRA) in adults and pediatric
individuals weighing at least 10 kg. Source: FDA website
|
New Indication | 12-18-20 |
Trikafta
The Food and Drug Administration (FDA)
approved Trikafta® (elexacaftor/tezacaftor/ivacaftor and
ivacaftor tablets) to include additional responsive
mutations in people with cystic fibrosis ages 12 and
older. Source: FDA website
|
Expanded Indication | 12-21-20 |
Symdeko
The Food and Drug Administration (FDA)
approved Symdeko® (tezacaftor/ivacaftor and ivacaftor)
to include additional responsive mutations in people
with cystic fibrosis ages 6 years and older. Source: FDA
website
|
Expanded Indication | 12-21-20 |
Kalydeco
The Food and Drug Administration (FDA)
approved Kalydeco® (ivacaftor tablets and oral granules)
to include additional responsive mutations in people
with cystic fibrosis ages 4 months and older. Source:
FDA website
|
Expanded Indication | 12-21-20 |
Ebanga
The Food and Drug Administration (FDA)
approved EbangaTM (ansuvimab-zykl injection) for the
treatment of Zaire ebolavirus infection in adults and
children. Source: FDA website
|
New Drug | 12-21-20 |
Gemtesa
The Food and Drug Administration (FDA)
approved Gemtesa® (vibegron tablets) for the treatment
of overactive bladder (OAB) with symptoms of urge
urinary incontinence, urgency, and urinary frequency in
adults. Source: FDA website
|
New Drug | 12-23-20 |
Klisyri
The Food and Drug Administration (FDA)
approved Klisyri® (tirbanibulin topical ointment) for
the treatment of actinic keratosis of the face or scalp.
Source: FDA website
|
New Drug | 12-14-20 |
Margenza
The Food and Drug Administration (FDA)
approved MargenzaTM (margetuximab-cmkb injection) in
combination with chemotherapy, for the treatment of
adults with metastatic human epidermal growth factor
receptor 2 (HER2)- positive breast cancer who have
received two or more prior anti-HER2 regimens, at least
one of which was for metastatic disease. Source: FDA
website
|
New Drug | 12-16-20 |
Orgovyx
The Food and Drug Administration (FDA)
approved OrgovyxTM (relugolix tablets) for the treatment
of adults with advanced prostate cancer. Source: FDA
website
|
New Drug | 12-18-20 |
Sunstar Americas
Sunstar Americas expands an earlier
voluntary recall of Paroex chlorhexidine gluconate oral
rinse. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse
Source: FDA website
|
Drug Recall | 12-29-20 |
Xalkori
The Food and Drug Administration (FDA)
approved Xalkori® (crizotinib capsules) for pediatric
individuals 1 year of age and older and young adults
with relapsed or refractory, systemic anaplastic large
cell lymphoma (ALCL) that is anaplastic lymphoma kinase
(ALK)-positive. Source: FDA website
|
Expanded Indication | 01-14-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one lot of metformin extended
release 750 mg tablets due to N-nitrosodimethylamine
(NDMA) content above the acceptable limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets
Source: FDA website
|
Drug Recall | 01-05-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one additional lot of extended
release metformin due to NDMA content above the
acceptable limit. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_medium=email&utm_source=govdelivery
Source: FDA website
|
Drug Recall | 01-06-21 |
Paroex
Precision Dose announced a voluntary
recall of all lots of Paroex® (chlorhexidine gluconate
oral rinse) due to potential for microbial
contamination. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp
Source: FDA website
|
Drug Recall | 01-05-21 |
Curative SARS-CoV-2 Test
The Food and Drug Administration (FDA)
is alerting healthcare providers and consumers of the
risk of false results with the Curative SARS-CoV-2 test.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication
Source: FDA website
|
Drug Warning | 01-07-21 |
Ketorolac tromethamine
Fresenius Kabi announced a voluntary
recall of a single lot of ketorolac tromethamine
injection due to the presence of particulate matter.
Contact your healthcare provider with questions. More
details may be viewed
at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp-due-presence
Source: FDA website
|
Drug Recall | 01-10-21 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with locally advanced or
metastatic human epidermal growth factor receptor 2
(HER2)-positive gastric or gastroesophageal (GEJ)
adenocarcinoma who have received a prior
trastuzumab-based regimen. Source: FDA website
|
New Indication | 01-15-21 |
Darzalex Faspro
The Food and Drug Administration (FDA)
approved Darzalex FasproTM
(daratumumab/hyaluronidase-fihj injection) for use in
combination with bortezomib, cyclophosphamide and
dexamethasone (VCd), to treat adults with newly
diagnosed light-chain (AL) amyloidosis. Source: FDA
website
|
New Indication | 01-15-21 |
Darzalex Faspro
The Food and Drug Administration (FDA)
approved Darzalex FasproTM
(daratumumab/hyaluronidase-fihj injection) for the
treatment of multiple myeloma in combination with
bortezomib, thalidomide, and dexamethasone in newly
diagnosed individuals who are eligible for autologous
stem cell transplant. Source: FDA website
|
New Indication | 01-11-21 |
Spritam
The Food and Drug Administration (FDA)
approved Spritam® (levetiracetam tablets) for the
treatment of partial-onset seizures in individuals 4
years of age and older weighing more than 20 kg. Source:
FDA website
|
Expanded Indication | 01-19-21 |
Verquvo
The Food and Drug Administration (FDA)
approved Verquvo® (vericiguat tablets) to reduce the
risk of cardiovascular death and heart failure (HF)
hospitalization following a hospitalization for heart
failure or need for outpatient IV diuretics, in adults
with symptomatic chronic HF and ejection fraction less
than 45%. Source: FDA website
|
New Drug | 01-20-21 |
Cabenuva
The Food and Drug Administration (FDA)
approved Cabenuva (cabotegravir/rilpivirine
extended-release injection) for the treatment of human
immunodeficiency virus (HIV)-1 infection in adults to
replace the current antiretroviral regimen in those who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine. Source: FDA website
|
New Drug | 01-21-21 |
Vocabria
The Food and Drug Administration (FDA)
approved Vocabria (cabotegravir tablets) in combination
with rilpivirine for short-term treatment of human
immunodeficiency virus (HIV)-1 infection in adults who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine, for use as: oral lead-in to assess the
tolerability of cabotegravir prior to administration of
Cabenuva (cabotegravir/rilpivirine extended-release
injection) or oral therapy for individuals who will miss
planned injection dosing with Cabenuva. Source: FDA
website
|
New Drug | 01-21-21 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) in combination
with Cabometyx (cabozantinib tablets) as first-line
treatment for individuals with advanced renal cell
carcinoma. Source: FDA website
|
Expanded Indication | 01-22-21 |
Edurant
The Food and Drug Administration (FDA)
approved Edurant® (rilpivirine tablets) in combination
with cabotegravir for short-term treatment of human
immunodeficiency virus (HIV)-1 infection in adults who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine, for use as: oral lead-in to assess the
tolerability of rilpivirine prior to administration of
Cabenuva (cabotegravir/rilpivirine extended-release
injection) or oral therapy for individuals who will miss
planned injection dosing with Cabenuva. Source: FDA
website
|
Expanded Indication | 01-21-21 |
Carbaglu
The Food and Drug Administration (FDA)
approved Carbaglu® (carglumic acid tablets for oral
suspension) for adjunctive treatment of acute
hyperammonemia due to propionic acidemia or
methylmalonic acidemia. Source: FDA website
|
New Indication | 01-22-21 |
Nplate
The Food and Drug Administration (FDA)
approved Nplate® (romiplostim injection) to increase
survival in adults and in pediatric individuals
(including term neonates) acutely exposed to
myelosuppressive doses of radiation. Source: FDA website
|
New Indication | 01-28-21 |
Lupkynis
The Food and Drug Administration (FDA)
approved LupkynisTM (voclosporin capsules) in
combination with a background immunosuppressive therapy
regimen for the treatment of adults with active lupus
nephritis. Source: FDA website
|
New Drug | 01-22-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one additional lot of extended
release metformin due to N-nitrosodimethylamine (NDMA)
content above the acceptable limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
Source: FDA website
|
Drug Recall | 01-26-21 |
Cisatracurium besylate
Meitheal Pharmaceuticals announced a
voluntary recall of one lot of Cisatracurium besylate
injection due to mislabeling. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meitheal-pharmaceuticals-inc-issues-voluntary-nationwide-recall-cisatracurium-besylate-injection-usp
Source: FDA website
|
Drug Recall | 01-28-21 |
Rapivab
The Food and Drug Administration (FDA)
approved Rapivab® (peramivir injection) for the
treatment of acute uncomplicated influenza in
individuals 6 months and older who have been symptomatic
for no more than two days. Source: FDA website
|
Expanded Indication | 01-28-21 |
Gocovri
The Food and Drug Administration (FDA)
approved Gocovri® (amantadine extended-release capsules)
as an adjunctive treatment to levodopa/carbidopa in
individuals with Parkinson’s disease experiencing OFF
episodes. Source: FDA website
|
New Indication | 02-01-21 |
Posimir
The Food and Drug Administration (FDA)
approved Posimir® (bupivacaine solution for infiltration
use) in adults for administration into the subacromial
space under direct arthroscopic visualization to produce
post-surgical analgesia for up to 72 hours following
arthroscopic subacromial decompression. Source: FDA
website
|
New Formulation | 02-01-21 |
Tepmetko
The Food and Drug Administration (FDA)
approved Tepmetko® (tepotinib tablets) for the treatment
of adults with metastatic non-small cell lung cancer
(NSCLC) harboring mesenchymal-epithelial transition
(MET) exon 14 skipping alterations. Source: FDA website
|
New Drug | 02-03-21 |
Enoxaparin sodium
Apotex announced a voluntary recall of
two lots of enoxaparin sodium injection due to
mislabeling of syringe barrel measurement markings.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-enoxaparin-sodium-injection-usp-due-mislabeling
Source: FDA website
|
Drug Recall | 02-03-21 |
Xeljanz and Xeljanz XR
The Food and Drug Administration (FDA)
is alerting consumers that preliminary results from a
safety clinical trial show an increased risk of serious
heart-related problems and cancer with the arthritis and
ulcerative colitis medicine Xeljanz® (tofacitinib
tablets) and Xeljanz® XR (tofacitinib extended-release
tablets) compared to another type of medicine called
tumor necrosis factor (TNF) inhibitors. The FDA required
the safety trial, which also investigated other
potential risks including blood clots in the lungs and
death. Those final results are not yet available.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-initial-safety-trial-results-find-increased
Source: FDA website
|
Drug Warning | 02-04-21 |
Libtayo
The Food and Drug Administration (FDA)
approved Libtayo® (cemiplimab-rwlc injection) for
individuals with advanced basal cell carcinoma (BCC)
previously treated with a hedgehog pathway inhibitor
(HHI) or for whom an HHI is not appropriate. Source: FDA
website
|
New Indication | 02-09-21 |
Botox
The Food and Drug Administration (FDA)
approved Botox® (onabotulinumtoxinA injection) for the
treatment of detrusor (bladder muscle) overactivity
associated with a neurologic condition in pediatric
individuals 5 years of age and older who have an
inadequate response to or are intolerant of
anticholinergic medication. Source: FDA website
|
New Indication | 02-09-21 |
Panzyga
The Food and Drug Administration (FDA)
approved Panzyga® (immune globulin injection) for the
treatment of adults with chronic inflammatory
demyelinating polyneuropathy (CIDP). Source: FDA
|
New Indication | 02-11-21 |
Ukoniq
The Food and Drug Administration (FDA)
approved Ukoniq® (umbralisib tablets) for the treatment
of adults with relapsed or refractory marginal zone
lymphoma (MZL) who have received at least one prior
anti-CD20-based regimen and relapsed or refractory
follicular lymphoma (FL) who have received at least
three prior lines of systemic therapy. Source: FDA
website
|
New Drug | 02-05-21 |
Breyanzi
The Food and Drug Administration (FDA)
approved Breyanzi® (lisocabtagene maraleucel suspension
for intravenous infusion) for the treatment of adults
with relapsed or refractory large B-cell lymphoma after
two or more lines of systemic therapy. Source: FDA
website
|
New Drug | 02-05-21 |
Evkeeza
The Food and Drug Administration (FDA)
approved EvkeezaTM (evinacumab-dgnb injection) as an
add-on treatment for individuals aged 12 years and older
with homozygous familial hypercholesterolemia (HoFH), a
genetic condition that causes severely high cholesterol.
Source: FDA website
|
New Drug | 02-11-21 |
Cosela
The Food and Drug Administration (FDA)
approved CoselaTM (trilaciclib injection) to reduce the
frequency of chemotherapy-induced bone marrow
suppression in adults receiving certain types of
chemotherapy for extensive-stage small cell lung cancer.
Source: FDA website
|
New Drug | 02-12-21 |
Entresto
The Food and Drug Administration (FDA)
approved Entresto® (sacubitril/valsartan tablets) in
chronic heart failure to include individuals with heart
failure with reduced ejection fraction (HFrEF), as well
as many with heart failure with preserved ejection
fraction (HFpEF). Source: FDA website
|
New Indication | 02-16-21 |
Libtayo
The Food and Drug Administration (FDA)
approved Libtayo® (cemiplimab-rwlc injection) for
individuals with advanced basal cell carcinoma (BCC)
previously treated with a hedgehog pathway inhibitor
(HHI) or for whom an HHI is not appropriate. Source: FDA
website
|
New Indication | 02-22-21 |
Humira
The Food and Drug Administration (FDA)
approved Humira® (adalimumab injection) for the
treatment of moderately to severely active ulcerative
colitis in pediatric individuals 5 years of age and
older. Source: FDA website
|
New Indication | 02-24-21 |
Amondys 45
The Food and Drug Administration (FDA)
approved Amondys 45 (casimersen injection) for the
treatment of Duchenne muscular dystrophy (DMD) in
individuals who have a confirmed mutation of the DMD
gene that is amenable to exon 45 skipping. Source: FDA
website
|
New Drug | 02-25-21 |
Nulibry
The Food and Drug Administration (FDA)
approved NulibryTM (fosdenopterin injection) to reduce
the risk of mortality in individuals with molybdenum
cofactor deficiency (MoCD) Type A. Source: FDA website
|
New Drug | 02-26-21 |
Pepaxto
The Food and Drug Administration (FDA)
approved Pepaxto® (melphalan flufenamide injection) in
combination with dexamethasone, for the treatment of
adults with relapsed or refractory multiple myeloma, who
have received at least four prior lines of therapy and
whose disease is refractory to at least one proteasome
inhibitor, one immunomodulatory agent, and one
CD38-directed monoclonal antibody. Source: FDA website
|
New Drug | 02-26-21 |
Fabrazyme
The Food and Drug Administration (FDA) approved Fabrazyme® (agalsidase beta injection) for the treatment of adult and pediatric individuals 2 years of age and older with Fabry disease. Source: FDA website
|
New Indication | 03-11-21 |
Arcalyst
The Food and Drug Administration (FDA) approved Arcalyst® (rilonacept injection) for the treatment of recurrent pericarditis and to reduce the risk of recurrence in individuals 12 years and older. Source: FDA website
|
New Indication | 03-18-21 |
Kimyrsa
The Food and Drug Administration (FDA) approved Kimyrsa™ (oritavancin injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). Source: FDA website
|
New Drug | 03-15-21 |
Ponvory
The Food and Drug Administration (FDA) approved Ponvory™ (ponesimod tablets) for the treatment of adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Source: FDA website
|
New Drug | 03-18-21 |
Phenylephrine
Sagent Pharmaceuticals announced a voluntary recall of three lots of phenylephrine hydrochloride injection due to potentially loose crimped vial overseals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection Source: FDA website
|
Drug Recall | 03-12-21 |