Drug Information
View drug alerts Information in California or 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 |
---|---|---|
Kalydeco
The Food and Drug Administration (FDA)
approved Kalydeco® (ivacaftor tablets and oral granules)
for use in children with cystic fibrosis (CF) ages 1
month to less than four months old who have at least one
mutation in their cystic fibrosis transmembrane
conductance regulator (CFTR) gene that is responsive to
Kalydeco based on clinical and/or in vitro assay data.
Source: FDA website
|
Expanded Indication | 5/3/2023 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) to reduce the
risk of cardiovascular death, hospitalization for heart
failure and urgent heart failure visit in adults with
heart failure (previously for adults with heart failure
and reduced ejection fraction). Source: FDA website
|
Expanded Indication | 5/8/2023 |
Rexulti
The Food and Drug Administration (FDA)
approved Rexulti® (brexpiprazole tablets) for use in the
treatment of agitation associated with dementia due to
Alzheimer’s disease. Source: FDA website
|
New Indication | 5/10/2023 |
Zolpidem
The Food and Drug Administration (FDA)
approved Zolpidem tartrate capsules for the short-term
treatment of transient insomnia characterized by
difficulties with sleep initiation in adults younger
than age 65 years of age. Source: FDA website
|
New Formulation | 5/9/2023 |
Motpoly XR
The Food and Drug Administration (FDA)
approved Motpoly XR (lacosamide extended-release
capsules) for the treatment of partial-onset seizures in
adults and in pediatric individuals weighing at least 50
kg. Source: FDA website
|
New Formulation | 5/4/2023 |
Elfabrio
The Food and Drug Administration (FDA)
approved Elfabrio® (pegunigalsidase alfa-iwxj injection)
for the treatment of adults with confirmed Fabry
disease. Source: FDA website
|
New Drug | 5/9/2023 |
Trikafta
The Food and Drug Administration (FDA)
approved Trikafta® (elexacaftor/tezacaftor/ivacaftor
tablets and oral granules) to include children with
cystic fibrosis (CF) ages 2 through 5 years who have at
least one F508del mutation in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene or a
mutation in the CFTR gene that is responsive to Trikafta
based on in vitro data. Source: FDA website
|
Expanded Indication | 4/26/2023 |
Prevnar 20
The Food and Drug Administration (FDA)
approved Prevnar 20TM (20-valent pneumococcal conjugate
vaccine injection) for the prevention of invasive
pneumococcal disease (IPD) caused by the 20
Streptococcus pneumoniae (pneumococcal) serotypes
contained in the vaccine in infants and children six
weeks through 17 years of age, and for the prevention of
otitis media in infants six weeks through five years of
age caused by the original seven serotypes contained in
Prevnar. Source: FDA website
|
Expanded Indication | 4/27/2023 |
Sogroya
The Food and Drug Administration (FDA)
approved Sogroya® (somapacitan-beco subcutaneous
injection) for the treatment of pediatric individuals
who have growth failure due to inadequate secretion of
endogenous growth hormone (GH). Source: FDA website
|
Expanded Indication | 4/28/2023 |
Liqrev
The Food and Drug Administration (FDA)
approved Liqrev® (sildenafil oral suspension) for the
treatment of pulmonary arterial hypertension (WHO Group
1) in adults to improve exercise ability and delay
clinical worsening. Source: FDA website
|
New Formulation | 4/28/2023 |
Lumryz
The Food and Drug Administration (FDA)
approved Lumryz™ (sodium oxybate extended-release oral
suspension) for the treatment of cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy.
Source: FDA website
|
New Formulation | 5/1/2023 |
Uzedy
The Food and Drug Administration (FDA)
approved Uzedy™ (risperidone extended-release injectable
suspension for subcutaneous use) for the treatment of
schizophrenia in adults. Source: FDA website
|
New Formulation | 4/28/2023 |
Abilify Asimtufii
The Food and Drug Administration (FDA)
approved Abilify Asimtufii® (aripiprazole
extended-release injectable suspension)for the treatment
of schizophrenia in adults and as maintenance
monotherapy treatment of bipolar I disorder in adults.
Source: FDA website
|
New Formulation | 4/28/2023 |
Zejula
The Food and Drug Administration (FDA)
approved Zejula™ (niraparib tablets) 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 and for maintenance
treatment of adults with deleterious or suspected
deleterious germline BRCA-mutated recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer
who are in a complete or partial response to
platinum-based chemotherapy. Source: FDA website
|
New Formulation | 4/26/2023 |
Qalsody
The Food and Drug Administration (FDA)
approved Qalsody™ (tofersen injection for intrathecal
use) for the treatment of amyotrophic lateral sclerosis
(ALS) in adults who have a mutation in the superoxide
dismutase 1 (SOD1) gene. Source: FDA website
|
New Drug | 4/25/2023 |
Vowst
The Food and Drug Administration (FDA)
approved Vowst™ (fecal microbiota spores, live-brpk
capsules) to prevent the recurrence of Clostridioides
difficile infection (CDI) in individuals 18 years of age
and older following antibacterial treatment for
recurrent CDI. Source: FDA website
|
New Drug | 4/26/2023 |
Arexvy
The Food and Drug Administration (FDA)
approved Arexvy (respiratory syncytial virus vaccine,
adjuvanted injection) for the prevention of lower
respiratory tract disease (LRTD) caused by respiratory
syncytial virus (RSV) in individuals 60 years of age and
older. Source: FDA website
|
New Drug | 5/3/2023 |
Akorn Operating Company
Akorn Operating Company announced a
voluntary recall of various within-expiry human and
animal products due to company closure. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due
Source: FDA website
|
Drug Recall | 4/26/2023 |
Fentanyl Buccal Tablets
Teva Pharmaceuticals announced a
voluntary recall of specific lots of various strengths
of fentanyl buccal tablets due to a labeling error.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling
Source: FDA website
|
Drug Recall | 4/27/2023 |
Qulipta
The Food and Drug Administration (FDA)
approved Qulipta™ (atogepant tablet) for the
preventative treatment of chronic migraines in adults.
Source: FDA website
|
Expanded Indication | 4/17/2023 |
Coagadex
The Food and Drug Administration (FDA)
approved Coagadex® (human coagulation factor X
injection) to include perioperative management of
bleeding in individuals with severe hereditary Factor X
deficiency. Source: FDA website
|
Expanded Indication | 4/14/2023 |
Polivy
The Food and Drug Administration (FDA)
approved Polivy® (polatuzumab vedotin-piiq injection) in
combination with rituximab, cyclophosphamide,
doxorubicin and prednisone (R-CHP) for the treatment of
adults who have previously untreated diffuse large
B-cell lymphoma (DLBCL), not otherwise specified (NOS)
or high-grade B-cell lymphoma (HGBL) and who have an
International Prognostic Index (IPI) score of two or
greater. Source: FDA website
|
Expanded Indication | 4/19/2023 |
Lupron Depot-Ped
The Food and Drug Administration (FDA)
approved Lupron Depot-Ped® (leuprolide acetate
injection) 45 mg single-dose, prefilled syringe for
6-month dosing regimen for the treatment of central
precocious puberty in pediatrics. Source: FDA website
|
New Formulation | 4/14/2023 |
RizaFilm
The Food and Drug Administration (FDA)
approved RizaFilm® (rizatriptan oral film) for the
treatment of acute migraine with or without aura in
adults and pediatric individuals 12 to 17 years of age
weighing 40 kg or more. Source: FDA website
|
New Formulation | 4/14/2023 |
Opioid Pain Medicines
The Food and Drug Administration (FDA)
is requiring several updates to the prescribing
information for immediate-release (IR) and
extended-release/long-acting (ER/LA) opioid pain
medicines. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/all-opioid-pain-medicines-drug-safety-communication-fda-updates-prescribing-information-provide
Source: FDA website
|
Drug Warning | 4/13/2023 |
Injectafer
The Food and Drug Administration (FDA)
approved Injectafer® (ferric carboxymaltose injection)
for the treatment of iron deficiency in adults with
heart failure and New York Heart Association Class
II/III to improve exercise capacity. Source: FDA website
|
New Indication | 5/31/2023 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) in combination
with abiraterone and prednisone (or prednisolone) for
adults with deleterious or suspected deleterious
BRCA-mutated (BRCAm) metastatic castration-resistant
prostate cancer (mCRPC), as determined by a Food and
Drug Administration (FDA)-approved companion diagnostic
test. Source: FDA website
|
New Indication | 5/31/2023 |
Prevymis
The Food and Drug Administration (FDA)
approved Prevymis™ (letermovir tablets and injection for
intravenous use) for prophylaxis of cytomegalovirus
(CMV) disease in adult kidney transplant recipients at
high risk (Donor CMV seropositive/Recipient
CMV-seronegative [D+/R-]). Source: FDA website
|
New Indication | 6/5/2023 |
Vevye
The Food and Drug Administration (FDA)
approved Vevye (cyclosporine ophthalmic solution) for
the treatment of the signs and symptoms of dry eye
disease. Source: FDA website
|
New Formulation | 5/30/2023 |
Inpefa
The Food and Drug Administration (FDA)
approved Inpefa™ (sotagliflozin tablets) to reduce the
risk of cardiovascular death, hospitalization for heart
failure, and urgent heart failure visit in adults with
heart failure or type 2 diabetes mellitus, chronic
kidney disease, and other cardiovascular risk factors.
Source: FDA website
|
New Drug | 5/26/2023 |
Abrysvo
The Food and Drug Administration (FDA)
approved Abrysvo™ (respiratory syncytial virus vaccine
injection) for the prevention of lower respiratory tract
disease caused by RSV in individuals 60 years and older.
Source: FDA website
|
New Drug | 5/31/2023 |
Compounded Semaglutide
The Food and Drug Administration (FDA)
communicated about medications containing semaglutide
marketed for type 2 diabetes or weight loss. There are
currently three FDA-approved semaglutide products which
are only available with a prescription. Due to two of
the drugs being in shortage, these are able to be
compounded if they meet certain requirements. The FDA
has received adverse event reports after people used
compounded semaglutide. The FDA has also received
reports that in some cases, compounders may be using
salt forms of semaglutide, including semaglutide sodium
and semaglutide acetate, which have not been shown to be
safe or effective. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
Source: FDA website
|
Drug Warning | 5/31/2023 |
Kevzara
The Food and Drug Administration (FDA)
approved Kevzara® (sarilumab injection) for the
treatment of polymyalgia rheumatica (PMR), an
inflammatory rheumatic disease, in adults who have had
an inadequate response to corticosteroids or who cannot
tolerate corticosteroid taper. Source: FDA website
|
New Indication | 2/28/2023 |
Verzenio
The Food and Drug Administration (FDA)
expanded approval of Verzenio® (abemaciclib tablets) for
the adjuvant treatment of adults with hormone
receptor-positive, human epidermal growth factor
receptor 2-negative, node-positive, early breast cancer
at high risk for recurrence. This approval also expands
the indication by removing the Ki-67 testing requirement
to identify high-risk patients. Source: FDA website
|
Expanded Indication | 3/3/2023 |
Naloxone hydrochloride
The Food and Drug Administration (FDA)
approved Naloxone hydrochloride 4 mg nasal spray for the
emergency treatment of known or suspected opioid
overdose, as manifested by respiratory and/or central
nervous system depression for adult and pediatric
individuals. Source: FDA website
|
New Formulation | 3/7/2023 |
Combogesic
The Food and Drug Administration (FDA)
approved Combogesic® (acetaminophen/ibuprofen tablets)
for the short-term management of mild to moderate acute
pain. Source: FDA website
|
New Formulation | 3/1/2023 |
Skyclarys
The Food and Drug Administration (FDA)
approved Skyclarys™ (omaveloxolone capsules) for the
treatment of Friedreich’s ataxia in adults and
adolescents aged 16 years and older. Source: FDA website
|
New Drug | 2/28/2023 |
Zavzpret
The Food and Drug Administration (FDA)
approved Zavzpret™ (zavegepant nasal spray) for the
acute treatment of migraine with or without aura in
adults. Source: FDA website
|
New Drug | 3/9/2023 |
Brimonidine tartrate
Apotex announced a voluntary recall
for six lots of brimonidine tartrate ophthalmic solution
due to cracks that have developed in some caps of
solution bottles. 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-brimonidine-tartrate-ophthalmic-solution-015-due
Source: FDA website
|
Drug Recall | 3/3/2023 |
Livmarli
The Food and Drug Administration (FDA)
expanded approval of Livmarli® (maralixibat oral
solution) to include the treatment of cholestatic
pruritus in individuals as young as 3 months old with
Alagille syndrome. Source: FDA website
|
Expanded Indication | 3/13/2023 |
Evkeeza
The Food and Drug Administration (FDA)
expanded approval of Evkeeza® (evinacumab-dgnb
injection) to include children ages 5 to 11 years for
the treatment of homozygous familial
hypercholesterolemia. Source: FDA website
|
Expanded Indication | 3/21/2023 |
Mekinist with Tafinlar
The Food and Drug Administration (FDA)
approved Mekinist® (trametinib tablets and oral
solution) with Tafinlar® (dabrafenib capsules and oral
solution) for pediatric individuals 1 year of age and
older with low-grade glioma (LGG) with a BRAF V600E
mutation who require systemic therapy. Source: FDA
website
|
New Indication | 3/16/2023 |
Daybue
The Food and Drug Administration (FDA)
approved Daybue™ (trofinetide oral solution) for the
treatment of Rett syndrome in adults and children 2
years of age and older. Source: FDA website
|
New Drug | 3/10/2023 |
Zynyz
The Food and Drug Administration (FDA)
approved Zynyz™ (retifanlimab-dlwr injection) for the
treatment of adults with metastatic or recurrent locally
advanced Merkel cell carcinoma. Source: FDA website
|
New Drug | 3/22/2023 |
Rezzayo
The Food and Drug Administration (FDA)
approved Rezzayo™ (rezafungin injection) for individuals
18 years or older who have limited or no alternative
options for the treatment of candidemia and invasive
candidiasis. Source: FDA website
|
New Drug | 3/22/2023 |
Dabigatran etexilate
Ascend Laboratories announced a
voluntary recall of dabigatran etexilate 75 mg and 150
mg capsules due to the presence of
N-nitrosodimethylamine (NDMA) impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg
Source: FDA website
|
Drug Recall | 3/23/2023 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) to include the
pediatric population for the adjuvant treatment of adult
and pediatric individuals 12 years and older with
melanoma with involvement of lymph nodes or metastatic
disease who have undergone complete resection. Source:
FDA website
|
Expanded Indication | 2/15/2023 |
Yervoy
The Food and Drug Administration (FDA)
approved Yervoy® (ipilimumab injection) to include the
pediatric population for the treatment of unresectable
or metastatic melanoma in adult and pediatric
individuals 12 years and older. Source: FDA website
|
Expanded Indication | 2/15/2023 |
Austedo XR
The Food and Drug Administration (FDA)
approved Austedo® XR (deutetrabenazine extended-release
tablets) in adults for tardive dyskinesia (TD) and
chorea associated with Huntington’s disease (HD).
Source: FDA website
|
New Formulation | 2/17/2023 |
Lamzede
The Food and Drug Administration (FDA)
approved Lamzede® (velmanase alfa-tycv) for the
treatment of non-central nervous system manifestations
of alpha-mannosidosis (AM) in adult and pediatric
individuals. Source: FDA website
|
New Drug | 2/16/2023 |
Filspari
The Food and Drug Administration (FDA)
approved Filspari™ (sparsentan tablets) to reduce
proteinuria in adults with primary immunoglobulin A
nephropathy (IgAN) at risk of rapid disease progression,
generally a urine protein-to-creatinine ratio (UPCR)
≥1.5 g/g. Source: FDA website
|
New Drug | 2/17/2023 |
Syfovre
The Food and Drug Administration (FDA)
approved Syfovre™ (pegcetacoplan intravitreal injection)
for the treatment of geographic atrophy (GA) secondary
to age-related macular degeneration. Source: FDA website
|
New Drug | 2/17/2023 |
Altuviiio
The Food and Drug Administration (FDA)
approved Altuviiio™ (antihemophilic factor
[recombinant], Fc-VWF-XTEN fusion protein-ehtl],
lyophilized powder for solution, for intravenous use)
for use in adults and children with hemophilia A
(congenital factor VIII deficiency) 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 | 2/22/2023 |
Descovy
The Food and Drug Administration (FDA)
approved Descovy® (emtricitabine/tenofovir alafenamide
fumarate tablets) to include treatment of human
immunodeficiency virus (HIV)-1 infection in pediatric
individuals at least 2 years of age and weighing at
least 14 kg.Source: FDA website
|
Expanded Indication | 01-07-22 |
Quviviq
The Food and Drug Administration (FDA)
approved Quviviq (daridorexant tablets) for the
treatment of adults with insomnia characterized by
difficulties with sleep onset and/or sleep
maintenance.Source: FDA website
|
New Drug | 01-07-22 |
Senna
Lohxa announced a voluntary recall of
one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups 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-senna-syrup-88mg5ml-due-microbial-contamination
Source: FDA website
|
Drug Recall | 01-13-22 |
Metformin
Viona Pharmaceuticals announced a
voluntary recall of twenty-three lots of metformin
hydrochloride extended-release tablets 750 mg due to
detection of N-nitrosamine (NDMA) impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
Source: FDA website
|
Drug Recall | 01-12-22 |
Buprenorphine
The Food and Drug Administration
(FDA) is warning that dental problems (tooth decay,
cavities, oral infection, and loss of teeth) have been
reported with medicines containing buprenorphine that
are dissolved in the mouth for opioid use disorder and
pain. The FDA is requiring a new warning be added to the
prescribing information. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines
Source: FDA website
|
Drug Warning | 01-12-22 |
Rinvoq
The Food and Drug Administration (FDA)
approved Rinvoq® (upadacitinib tablets) for the
treatment of adults and children 12 years of age and
older with refractory, moderate-to-severe atopic
dermatitis (AD) whose disease is not adequately
controlled with other systemic drug products, including
biologics, or when use of those therapies is
inadvisable. Source: FDA website
|
New Indication | 01-14-22 |
Skyrizi
The Food and Drug Administration (FDA)
approved SkyriziTM (risankizumab-rzaa injection) for the
treatment of adults with active psoriatic arthritis
(PsA). Source: FDA website
|
New Indication | 01-24-22 |
Veklury
The Food and Drug Administration (FDA)
approved Veklury® (remdesivir injection) for the
treatment of coronavirus disease 2019 (COVID-19) in
adults and pediatric individuals (12 years of age and
older and weighing at least 40 kg) with positive results
of direct severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) viral testing, who are not hospitalized
and have mild-to-moderate COVID-19, and are at high risk
for progression to severe COVID-19, including
hospitalization or death. Source: FDA website
|
Expanded Indication | 01-21-22 |
Ryaltris
The Food and Drug Administration (FDA)
approved RyaltrisTM (olopatadine
hydrochloride/mometasone furoate nasal spray) for the
treatment of symptoms of seasonal allergic rhinitis in
adults and pediatric individuals 12 years of age and
older. Source: FDA website
|
New Formulation | 01-13-22 |
Cibinqo
The Food and Drug Administration (FDA)
approved CibinqoTM (abrocitinib tablets) for the
treatment of adults with refractory, moderate-to-severe
atopic dermatitis (AD) whose disease is not adequately
controlled with other systemic drug products, including
biologics, or when use of those therapies is
inadvisable. Source: FDA website
|
New Drug | 01-14-22 |
Semglee
Mylan Pharmaceuticals announced a
voluntary recall of one batch of its non-interchangeable
Semglee injection due to the potential for a missing
label. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin
Source: FDA website
|
Drug Recall | 01-19-22 |
Solosec
The Food and Drug Administration (FDA)
approved Solosec® (secnidazole oral granules) for the
treatment of bacterial vaginosis and trichomoniasis
caused by Trichomonas vaginalis in individuals 12 years
of age and older. Source: FDA website
|
Expanded Indication | 01-26-22 |
Pifeltro
The Food and Drug Administration
(FDA) approved Pifeltro® (doravirine tablets) for the
treatment of human immunodeficiency virus (HIV)-1 in
pediatric individuals weighing at least 35 kg. Source:
FDA website
|
Expanded Indication | 01-27-22 |
Delstrigo
The Food and Drug Administration (FDA)
approved DelstrigoTM (doravirine/lamivudine/tenofovir
disoproxil fumarate tablets) for the treatment of human
immunodeficiency virus (HIV)-1 in pediatric individuals
weighing at least 35 kg. Source: FDA website
|
Expanded Indication | 01-27-22 |
Vonvendi
The Food and Drug Administration (FDA)
approved Vonvendi® (recombinant von Willebrand factor
injection) for routine prophylaxis to reduce the
frequency of bleeding episodes in individuals with
severe Type 3 von Willebrand disease (VWD) receiving
on-demand therapy. Source: FDA website
|
Expanded Indication | 01-31-22 |
Nucala
The Food and Drug Administration (FDA)
approved Nucala (mepolizumab 40 mg prefilled syringe
injection) as add-on maintenance treatment for children
6 to 11 years of age with severe asthma and with an
eosinophilic phenotype. Source: FDA website
|
New Formulation | 01-22-22 |
Kimmtrak
The Food and Drug Administration (FDA)
approved Kimmtrak® (tebentafusp-tebn injection) for the
treatment of human leukocyte antigen
(HLA)-A*02:01-positive adults with unresectable or
metastatic uveal melanoma (mUM). Source: FDA website
|
New Drug | 01-26-22 |
Vabysmo
The Food and Drug Administration (FDA)
approved VabysmoTM (faricimab-svoa injection for
intravitreal use) for the treatment of adults with
neovascular age-related macular degeneration (nAMD) or
diabetic macular edema (DME). Source: FDA website
|
New Drug | 01-28-22 |
Polymyxin B
AuroMedics Pharma announced a
voluntary recall of one lot of polymyxin B for injection
due to a product complaint for 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/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial
Source: FDA website
|
Drug Recall | 01-28-22 |
Xigduo XR
The Food and Drug Administration (FDA)
approved Xigduo® XR (dapagliflozin/metformin
hydrochloride extended-release tablets) to reduce the
risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure (NYHA class
II-IV) with reduced ejection fraction. Source: FDA
website
|
New Indication | 02-03-22 |
Fleqsuvy
The Food and Drug Administration
(FDA) approved FleqsuvyTM (baclofen oral suspension) for
the treatment of spasticity resulting from multiple
sclerosis (MS), particularly for the relief of flexor
spasms and concomitant pain, clonus, and muscular
rigidity. Source: FDA website
|
New Formulation | 02-04-22 |
Enjaymo
The Food and Drug Administration (FDA)
approved EnjaymoTM (sutimlimab-jome injection) to
decrease the need for red blood cell (RBC) transfusion
due to hemolysis in adults with cold agglutinin disease
(CAD). Source: FDA website
|
New Drug | 02-04-22 |
Ukoniq
The Food and Drug Administration (FDA)
is investigating a possible increased risk of death due
to the cancer drug Ukoniq® (umbralisib tablets). The FDA
is re-evaluating the risk versus benefit of Ukoniq and
is continuing to look at results from the UNITY clinical
trial. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma
Source: FDA website
|
Drug Warning | 02-03-22 |
Jardiance
The Food and Drug Administration
(FDA) approved Jardiance® (empagliflozin tablets) to
treat adults with heart failure regardless of left
ventricular ejection fraction. Source: FDA website
|
Expanded Indication | 02-24-22 |
Norliqva
The Food and Drug Administration (FDA)
approved Norliqva® (amlodipine oral solution) for the
treatment of hypertension in adults and children 6 years
and older and for the treatment of coronary artery
disease and angiographically documented coronary artery
disease in individuals without heart failure or an
ejection fraction <40%. Source: FDA website
|
New Formulation | 02-24-22 |
Aspruzyo Sprinkle
The Food and Drug Administration
(FDA) approved Aspruzyo SprinkleTM (ranolazine
extended-release oral granules) for the treatment of
chronic angina. Source: FDA website
|
New Formulation | 02-28-22 |
Pyrukynd
The Food and Drug Administration (FDA)
approved Pyrukynd® (mitapivat tablets) for the treatment
of hemolytic anemia in adults with pyruvate kinase (PK)
deficiency. Source: FDA website
|
New Drug | 02-17-22 |
Carvykti
The Food and Drug Administration
(FDA) approved CarvyktiTM (ciltacabtagene autoleucel
suspension for intravenous infusion) for the treatment
of adults with relapsed or refractory multiple myeloma,
after four or more prior lines of therapy, including a
proteasome inhibitor, an immunomodulatory agent, and an
anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 02-28-22 |
Vonjo
The Food and Drug Administration
(FDA) approved VonjoTM (pacritinib capsules) for the
treatment of adults with intermediate or high-risk
primary or secondary (post-polycythemia vera or
post-essential thrombocythemia) myelofibrosis with a
platelet count below 50 × 109/L. Source: FDA website
|
New Drug | 02-28-22 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) in combination
with platinum-doublet chemotherapy for adults with
resectable non-small cell lung cancer (NSCLC) in the
neoadjuvant setting. Source: FDA website
|
Expanded Indication | 03-04-22 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) for the adjuvant
treatment of adults with deleterious or suspected
deleterious germline BRCA-mutated (gBRCAm) human
epidermal growth factor receptor 2 (HER2)-negative
high-risk early breast cancer who have been treated with
neoadjuvant or adjuvant chemotherapy. Source: FDA
website
|
Expanded Indication | 03-11-22 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) as a single
agent for individuals with advanced endometrial
carcinoma that is microsatellite instability-high
(MSI-H) or mismatch repair deficient (dMMR), as
determined by a Food and Drug Administration
(FDA)-approved test, who have disease progression
following prior systemic therapy in any setting and who
are not candidates for curative surgery or radiation.
Source: FDA website
|
Expanded Indication | 03-21-22 |
Smoflipid
The Food and Drug Administration (FDA)
approved Smoflipid® (lipid injectable emulsion) as a
source of calories and essential fatty acids for
parenteral nutrition when oral or enteral nutrition is
not possible, insufficient, or contraindicated expanded
to include pediatric individuals. Source: FDA website
|
Expanded Indication | 03-22-22 |
Rinvoq
The Food and Drug Administration
(FDA) approved Rinvoq® (upadacitinib extended-release
tablets) for the treatment of adults with moderately to
severely active ulcerative colitis (UC) who have had an
inadequate response or intolerance to one or more tumor
necrosis factor (TNF) blockers. Source: FDA website
|
New Indication | 03-16-22 |
Adlarity
The Food and Drug Administration
(FDA) approved Adlarity® (donepezil transdermal system)
for the treatment of adults with mild, moderate, and
severe dementia of the Alzheimer type. Source: FDA
website
|
New Formulation | 03-11-22 |
Xelstrym
The Food and Drug Administration
(FDA) approved XelstrymTM (dextroamphetamine transdermal
system) for the treatment of
attention-deficit/hyperactivity disorder (ADHD) for
adults and pediatric individuals 6 years and older.
Source: FDA website
|
New Formulation | 03-23-22 |
Hyftor
The Food and Drug Administration (FDA)
approved HyftorTM (sirolimus topical gel) for the
treatment of facial angiofibroma associated with
tuberous sclerosis in adults and pediatric individuals 6
years of age and older. Source: FDA website
|
New Formulation | 03-22-22 |
Ztalmy
The Food and Drug Administration (FDA)
approved Ztalmy® (ganaxolone oral suspension) for the
treatment of seizures associated with cyclin-dependent
kinase-like 5 (CDKL5) deficiency disorder (CDD) in
individuals 2 years of age or older. Source: FDA website
|
New Drug | 03-18-22 |
Opdualag
The Food and Drug Administration
(FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw
injection) for the treatment of adult and pediatric
individuals 12 years of age or older with unresectable
or metastatic melanoma. Source: FDA website
|
New Drug | 03-18-22 |
Pluvicto
The Food and Drug Administration (FDA)
approved PluvictoTM (lutetium Lu 177 vipivotide
tetraxetan injection) for the treatment of adults with
prostate-specific membrane antigen (PSMA)-positive
metastatic castration-resistant prostate cancer (mCRPC)
who have been treated with androgen receptor (AR)
pathway inhibition and taxane-based chemotherapy.
Source: FDA website
|
New Drug | 03-23-22 |
Sodium acetate
Fresenius Kabi announced a voluntary
recall of seven lots of sodium acetate 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-recall-sodium-acetate-injection-usp-due-presence-particulate-matter
Source: FDA website
|
Drug Recall | 03-08-22 |
Quinapril/hydrochlorothiazide
Pfizer announced a voluntary recall of
six lots of AccureticTM (quinapril
HCL/hydrochlorothiazide) tablets distributed by Pfizer
as well as five lots of two authorized generics
distributed by Greenstone due to the presence 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/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and
Source: FDA website
|
Drug Recall | 03-22-22 |
Orphenadrine citrate
Sandoz announced a voluntary recall
of 13 lots of oral orphenadrine citrate 100 mg
extended-release tablets due to the presence 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/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due
Source: FDA website
|
Drug Recall | 03-23-22 |
Symjepi
Adamis Pharmaceuticals announced a
voluntary recall of certain lots of SymjepiTM
(epinephrine injection) due to the potential clogging of
the needle preventing the dispensing of epinephrine.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection
Source: FDA website
|
Drug Recall | 03-22-22 |
Fintepla
The Food and Drug Administration
(FDA) approved Fintepla® (fenfluramine oral solution)
for the treatment of seizures associated with
Lennox-Gastaut syndrome in individuals two years of age
and older. Source: FDA website
|
New Indication | 03-25-22 |
Cabenuva
The Food and Drug Administration (FDA)
approved Cabenuva (cabotegravir extended-release
injectable suspension and rilpivirine extended-release
injectable suspension) for expanded use of every 2-month
dosing regimen to include the treatment of human
immunodeficiency virus (HIV)-1 infection in adolescents
12 years of age and older and weighing at least 35 kg.
Source: FDA website
|
Expanded Indication | 03-29-22 |
Vocabria and Edurant
The Food and Drug Administration
(FDA) approved Vocabria (cabotegravir tablets) for
expanded use in combination with Edurant® (rilpivirine
tablets) as an oral, short-term treatment regimen
followed by Cabenuva injection dosing regimen for the
treatment of human immunodeficiency virus (HIV)-1 virus
infection in adolescents 12 years of age and older and
weighing at least 35 kg. Source: FDA website
|
Expanded Indication | 03-29-22 |
Tlando
The Food and Drug Administration
(FDA) approved TlandoTM (testosterone undecanoate oral
capsule) for testosterone replacement therapy in adult
males for conditions associated with a deficiency or
absence of endogenous testosterone. Source: FDA website
|
New Formulation | 03-28-22 |
Triumeq PD
The Food and Drug Administration (FDA)
approved Triumeq PD (abacavir/dolutegravir/lamivudine
dispersible tablets for oral suspension) for the
treatment of pediatric individuals weighing 10 kg to <
25 kg with human immunodeficiency virus type 1
(HIV-1). The original tablet formulation of
Triumeq was also expanded to individuals
weighing at least 10 kg. Source: FDA website
|
New Formulation | 03-30-22 |
Idarubicin
Teva Pharmaceuticals announced a
voluntary recall of one lot of idarubicin hydrochloride
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/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due
Source: FDA website
|
Drug Recall | 03-30-22 |
North American Custom Laboratories
The Food and Drug Administration
(FDA) issued a warning not to use products intended to
be sterile produced by North American Custom
Laboratories due to a lack of sterility assurance.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery
Source: FDA website
|
Drug Warning | 03-31-22 |
Iodine-containing contrast media
The Food and Drug Administration (FDA)
approved a new warning to the prescribing label for the
entire class of iodinated contrast media injections and
monitoring recommendations for children 3 years or
younger. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies
Source: FDA website
|
Drug Warning | 03-31-22 |
Yescarta
The Food and Drug Administration
(FDA) approved Yescarta® (axicabtagene ciloleucel for
intravenous infusion) for adults with large B-cell
lymphoma (LBCL) that is refractory to first-line
chemoimmunotherapy or relapses within 12 months of
first-line chemoimmunotherapy. Source: FDA website
|
Expanded Indication | 04-01-22 |
Igalmi
The Food and Drug Administration (FDA)
approved IgalmiTM (dexmedetomidine sublingual film) for
the acute treatment of agitation associated with
schizophrenia or bipolar I or II disorder in adults.
Source: FDA website
|
New Formulation | 04-05-22 |
Vijoice
The Food and Drug Administration (FDA)
approved Vijoice® (alpelisib tablets) for the treatment
of adult and pediatric individuals 2 years of age and
older with severe manifestations of PIK3CA-related
overgrowth spectrum (PROS) who require systemic therapy.
Source: FDA website
|
New Formulation | 04-05-22 |
Xigduo XR
The Food and Drug Administration
(FDA) approved Xigduo® XR (dapagliflozin/metformin
extended-release tablet) to reduce the risk of sustained
estimated glomerular filtration rate decline, end stage
kidney disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic
kidney disease at risk of progression. Source: FDA
website
|
Expanded Indication | 04-11-22 |
Insulin glargine
Mylan Pharmaceuticals announced a
voluntary recall of one batch of insulin glargine
injection due to the potential for a missing label.
Contact your healthcare provider for questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin
Source: FDA website
|
Drug Recall | 04-13-22 |
Zerbaxa
The Food and Drug Administration (FDA)
approved Zerbaxa® (ceftolozane sulfate/tazobactam sodium
injection) in pediatric individuals from birth to less
than 18 years of age for the treatment of complicated
urinary tract infections (cUTI), including
pyelonephritis, and complicated intra-abdominal
infections (cIAI). Source: FDA website
|
Expanded Indication | 04-21-22 |
Ultomiris
The Food and Drug Administration
(FDA) approved Ultomiris® (ravulizumab-cwvz injection)
for the treatment of adults with generalized myasthenia
gravis (gMG) who are anti-acetylcholine receptor (AChR)
antibody-positive. Source: FDA website
|
New Indication | 04-27-22 |
Epsolay
The Food and Drug Administration
(FDA) approved Epsolay® (benzoyl peroxide cream) for the
treatment of inflammatory lesions of rosacea in adults.
Source: FDA website
|
New Formulation | 04-22-22 |
Cuvrior
The Food and Drug Administration (FDA)
approved CuvriorTM (trientine tetrahydrochloride
tablets) for the treatment of adult patients with stable
Wilson’s disease who are de-coppered and tolerant to
penicillamine. Source: FDA website
|
New Formulation | 04-28-22 |
Vivjoa
The Food and Drug Administration (FDA)
approved VivjoaTM (oteseconazole capsules) to reduce the
incidence of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC who are not of
reproductive potential. Source: FDA website
|
New Drug | 04-27-22 |
Camzyos
The Food and Drug Administration (FDA)
approved CamzyosTM (mavacamten capsules) for the
treatment of adults with symptomatic New York Heart
Association (NYHA) class II-III obstructive hypertrophic
cardiomyopathy (HCM) to improve functional capacity and
symptoms. Source: FDA website
|
New Drug | 04-28-22 |
Accupril
Pfizer announced a voluntary recall of
five lots of Accupril due to the presence of a
nitrosamine above the acceptable level. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content
Source: FDA website
|
Drug Recall | 04-23-22 |
Rinvoq
The Food and Drug Administration
(FDA) approved Rinvoq® (upadacitinib extended-release
tablets) for the treatment of adults with active
ankylosing spondylitis (AS) who have had an inadequate
response or intolerance to one or more tumor necrosis
factor (TNF) blockers. Source: FDA website
|
New Indication | 04-29-22 |
Olumiant
The Food and Drug Administration
(FDA) approved Olumiant® (baricitinib tablets) for the
treatment of COVID-19 in hospitalized adults requiring
supplemental oxygen, non-invasive or invasive mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO). Source: FDA approval
|
New Indication | 05-10-22 |
Qelbree
The Food and Drug Administration (FDA)
approved Qelbree® (viloxazine extended-release capsules)
for the treatment of attention deficit hyperactivity
disorder (ADHD) in adults aged 18 and older. Source: FDA
website
|
Expanded Indication | 05-02-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for the treatment of adults with unresectable
or metastatic human epidermal growth factor receptor 2
(HER2) positive breast cancer who have received a prior
anti-HER2-based regimen either in the metastatic
setting, or in the neoadjuvant or adjuvant setting and
have developed disease recurrence during or within six
months of completing therapy. Source: FDA website
|
Expanded Indication | 05-04-22 |
Ermeza
The Food and Drug Administration (FDA)
approved ErmezaTM (levothyroxine sodium oral solution)
in adult and pediatric individuals, including neonates,
as replacement therapy in primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) congenital or
acquired hypothyroidism. Also approved as an adjunct to
surgery and radioiodine therapy in the management of
thyrotropin-dependent well-differentiated thyroid
cancer. Source: FDA website
|
New Formulation | 04-29-22 |
Radicava ORS
The Food and Drug Administration (FDA)
approved Radicava ORS® (edaravone oral suspension) for
the treatment of adults with amyotrophic lateral
sclerosis (ALS). Source: FDA website
|
New Formulation | 05-12-22 |
Mounjaro
The Food and Drug Administration
(FDA) approved MounjaroTM (tirzepatide subcutaneous
injection) to improve blood sugar control in adults with
type 2 diabetes as an addition to diet and exercise.
Source: FDA website
|
New Drug | 05-12-22 |
Voquezna Triple Pak and Voquezna Dual Pak
The Food and Drug Administration (FDA)
approved VoqueznaTM Triple PakTM (vonoprazan
tablets/amoxicillin capsules/ clarithromycin tablets
co-packaged for oral use) and VoqueznaTM Dual PakTM
(vonoprazan tablets/amoxicillin capsules/co-packaged for
oral use) for the treatment of Helicobacter pylori (H.
pylori) infection in adults. Source: FDA website
|
New Drug | 05-03-22 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection)
to treat eosinophilic esophagitis (EoE) in adults and
pediatric individuals 12 years and older
weighing at least 40 kg. Source: FDA website
|
New Indication | 05-20-22 |
Vidaza
The Food and Drug Administration (FDA)
approved Vidaza® (azacitidine injection)
for pediatric individuals with newly diagnosed juvenile
myelomonocytic leukemia. Source: FDA website
|
New Indication | 05-20-22 |
Tibsovo
The Food and Drug Administration (FDA)
approved Tibsovo® (ivosidenib tablet)
in combination with azacitidine for newly diagnosed
acute myeloid leukemia (AML) with a susceptible IDH1
mutation,
as detected by an FDA-approved test in adults 75 years
or older, or who have comorbidities that preclude use of
intensive induction chemotherapy. Source: FDA website
|
Expanded Indication | 05-25-22 |
TPOXX
The Food and Drug Administration (FDA)
approved TPOXX®
(tecovirimat intravenous) for the treatment of human
smallpox disease in adults
and pediatric individuals weighing at least 3 kg.
Source: FDA website
|
New Formulation | 05-18-22 |
Tyvaso DPI
The Food and Drug Administration (FDA)
approved Tyvaso DPI™ (treprostinil oral
inhalation)
for the treatment of individuals with pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). Source: FDA
website
|
New Formulation | 05-23-22 |
Vtama
The Food and Drug Administration (FDA)
approved Vtama®
(tapinarof topical cream) for the treatment of plaque
psoriasis in adults. Source: FDA website
|
New Drug | 05-24-22 |
Anagrelide
Teva Pharmaceuticals announced a
voluntary recall of a single lot of anagrelide
capsules due to dissolution test failure. Contact your
healthcare provider with details.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test
Source: FDA website
|
Drug Recall | 05-23-22 |
Evrysdi
The Food and Drug Administration (FDA)
approved Evrysdi® (risdiplam oral solution) to include
treatment of infants under 2 months old with spinal
muscular atrophy (SMA). Source: FDA website
|
Expanded Indication | 05-27-22 |
Opdivo
The Food and Drug Administration
(FDA) approved Opdivo® (nivolumab injection) in
combination with fluoropyrimidine- and
platinum-containing chemotherapy and Opdivo plus Yervoy
(ipilimumab injection) as a first-line treatment for
adults with unresectable advanced or metastatic
esophageal squamous cell carcinoma (ESCC) regardless of
programmed death-ligand 1 (PD-L1) status. Source: FDA
website
|
Expanded Inciation | 05-27-22 |
Kymriah
The Food and Drug Administration (FDA)
approved Kymriah® (tisagenlecleucel injection) for the
treatment of adults with relapsed or refractory
follicular lymphoma (FL) after two or more lines of
systemic therapy. Source: FDA website
|
Expanded Inciation | 05-28-22 |
Beovu
The Food and Drug Administration
(FDA) approved Beovu® (brolucizumab-dbll) for the
treatment of diabetic macular edema (DME). Source: FDA
website
|
New Indication | 05-27-22 |
Ukoniq
The Food and Drug Administration
(FDA) has withdrawn approval for the cancer medication
UkoniqTM (umbralisib tablet) due to safety concerns.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-approval-lymphoma-medicine-withdrawn-due-safety
Source: FDA website
|
Drug Warning | 06-01-22 |
CellCept
The Food and Drug Administration (FDA)
approved CellCept® (mycophenolate mofetil capsule,
tablet, oral suspension, and injection) for the
prophylaxis of organ rejection in pediatric recipients
of allogenic heart and allogenic liver transplants aged
3 months and older in combination with other
immunosuppressants. Source: FDA website
|
Expanded Indication | 06-06-22 |
Dupixent
The Food and Drug Administration
(FDA) approved Dupixent® (dupilumab injection) for the
treatment of children aged 6 months to 5 years with
moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with topical prescription
therapies or for when those therapies are not advisable.
Source: FDA website
|
Expanded Indication | 06-07-22 |
Priorix
The Food and Drug Administration
(FDA) approved Priorix (measles, mumps, and rubella
vaccine, live suspension for subcutaneous injection) for
active immunization for the prevention of measles,
mumps, and rubella in individuals 12 months of age and
older. Source: FDA website
|
New Formulation | 06-03-22 |
Olumiant
The Food and Drug Administration (FDA)
approved Olumiant® (baricitinib tablets) for the
treatment of adults with severe alopecia areata. Source:
FDA website
|
New Indication | 06-13-22 |
Imcivree
The Food and Drug Administration
(FDA) approved ImcivreeTM (setmelanotide subcutaneous
injection) for chronic weight management in adult and
pediatric individuals 6 years of age and older with
obesity due to Bardet-Biedl Syndrome (BBS). Source: FDA
website
|
New Indication | 06-16-22 |
Skyrizi
The Food and Drug Administration (FDA)
approved Skyrizi® (risankizumab-rzaa injection) for the
treatment of adults with moderately to severely active
Crohn's disease. Source: FDA website
|
New Indication | 06-17-22 |
Amvuttra
The Food and Drug Administration (FDA)
approved AmvuttraTM (vutrisiran subcutaneous injection)
for the treatment of the polyneuropathy of hereditary
transthyretin-mediated amyloidosis in adults. Source:
FDA website
|
New Drug | 06-13-22 |
Zulresso
The Food and Drug Administration
(FDA) approved ZulressoTM (brexanolone injection for
intravenous use) for expansion to include individuals 15
years and older diagnosed with postpartum depression.
Source: FDA website
|
Expanded Indication | 06-16-22 |
Vaxneuvance
The Food and Drug Administration
(FDA) approved VaxneuvanceTM (pneumococcal 15-valent
conjugate vaccine intramuscular injection) expanded for
active immunization for the prevention of invasive
disease caused by certain Streptococcus pneumoniae
serotypes in individuals 6 weeks of age and older.
Source: FDA website
|
Expanded Indication | 06-22-22 |
Mekinist plus Tafinlar
The Food and Drug Administration (FDA)
approved Mekinist® (trametinib tablets) plus Tafinlar®
(dabrafenib capsules) for the treatment of adult and
pediatric individuals 6 years of age and older with
unresectable or metastatic solid tumors with BRAF V600E
mutation who have progressed following prior treatment
and have no satisfactory alternative treatment options.
Source: FDA website
|
Expanded Indication | 06-22-22 |
Breyanzi
The Food and Drug Administration (FDA)
approved Breyanzi® (lisocabtagene maraleucel suspension
for intravenous infusion) for the treatment of adults
with large B-cell lymphoma (LBCL) after one prior
therapy. Source: FDA website
|
Expanded Indication | 06-24-22 |
Qsymia
The Food and Drug Administration (FDA)
approved Qsymia® (phentermine/topiramate
extended-release capsules) for chronic weight management
in pediatric individuals aged 12 years and older who are
obese, defined as a body mass index (BMI) of 95th
percentile or greater when standardized for age and sex.
Source: FDA website
|
Expanded Indication | 06-24-22 |
Morphine sulfate
Bryant Ranch Prepack announced a
voluntary recall of one lot of morphine sulfate 30 mg
extended-release tablets and one lot of morphine sulfate
60 mg extended-release tablets due to incorrect
labeling. 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-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release
Source: FDA website
|
Drug Recall | 06-29-22 |
Kyprolis
The Food and Drug Administration (FDA)
approved Kyprolis® (carfilzomib injection) in
combination with Sarclisa® (isatuximab-irfc injection)
and dexamethasone for the treatment of adults with
relapsed or refractory multiple myeloma (RRMM) who have
received one to three lines of therapy. Source: FDA
website
|
Expanded Indication | 06-30-22 |
Krystexxa
The Food and Drug Administration (FDA)
approved Krystexxa® (pegloticase injection) for
concomitant use with methotrexate for the treatment of
individuals with uncontrolled gout to achieve a complete
response to therapy. Source: FDA website
|
Expanded Indication | 07-07-22 |
Drospirenone
The Food and Drug Administration (FDA)
approved Drospirenone chewable tablets for use by
females of reproductive potential to prevent pregnancy.
Source: FDA website
|
New Formulation | 09-29-22 |
Venbysi XR
The Food and Drug Administration (FDA)
approved Venbysi XR (venlafaxine besylate
extended-release oral tablets) for the treatment of
major depressive disorder and generalized anxiety
disorder in adults. Source: FDA website
|
New Formulation | 09-29-22 |
Insulin glargine
Mylan Pharmaceuticals announced a
voluntary recall of one batch of insulin glargine
injection due to the potential of missing labels on some
pens. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-issues-voluntary-nationwide-recall-one-batch-insulin
Source: FDA website
|
Drug Recall | 07-06-22 |
Copiktra
The Food and Drug Administration (FDA)
is warning that results from a clinical trial show a
possible increased risk of death and serious adverse
events with the oncology medicine Copiktra® (duvelisib
capsules). The FDA will continue to evaluate the safety
of this agent. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/copiktra-duvelisib-drug-safety-communication-fda-warns-about-possible-increased-risk-death-and
Source: FDA website
|
Drug Warning | 06-30-22 |
Xalkori
The Food and Drug Administration (FDA) approved Xalkori® (crizotinib oral pellets) 20 mg, 50 mg, and 150 mg oral pellets to for all previously approved indications. Source: FDA website
|
New Formulation | 9/7/2023 |
Temodar
The Food and Drug Administration (FDA) approved Temodar® (temozolomide injection) for the adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and the treatment of adults with refractory anaplastic astrocytoma. Source: FDA website
|
Expanded Indication | 9/14/2023 |
Aphexda
The Food and Drug Administration (FDA) approved AphexdaTM (motixafortide subcutaneous injection) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma, in combination with filgrastim (granulocyte-colony stimulating factor [G-CSF]). Source: FDA website
|
New Drug | 9/8/2023 |
Ojjaara
The Food and Drug Administration (FDA) approved Ojjaara (momelotinib tablets) for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. Source: FDA website
|
New Drug | 9/15/2023 |
Sandimmune
Novartis announced a voluntary recall of one lot of Sandimmune® (cyclosporine oral solution) 100 mg/mL due to crystal formation observed in some bottles. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral Source: FDA website
|
Drug Recall | 9/11/2023 |
Opzelura
The Food and Drug Administration (FDA) approved
Opzelura™ (ruxolitinib cream)
for the topical treatment of nonsegmental vitiligo in
adult and pediatric individuals
12 years of age and older. Source: FDA website
|
New Indication | 07-18-22 |
Diacomit
The Food and Drug Administration (FDA)
approved Diacomit® (stiripentol capsules)
for the treatment of seizures associated with Dravet
syndrome (DS) in individuals
taking clobazam who are 6 months of age and older and
weighing 7 kg or more. Source: FDA website
|
Expanded Indication | 07-14-22 |
Zonisade
The Food and Drug Administration (FDA)
approved Zonisade™ (zonisamide oral suspension)
as adjunctive therapy for the treatment of partial onset
seizures in adults and pediatric
individuals 16 years of age and older. Source: FDA
website
|
New Formulation | 07-15-22 |
Benlysta
The Food and Drug Administration (FDA)
approved Benlysta® (belimumab injection) to include
pediatric individuals 5 to 17 years of age with active
lupus nephritis who are receiving standard therapy.
Source: FDA website
|
Expanded Indication | 07-26-22 |
Stelara
The Food and Drug Administration (FDA)
approved Stelara® (ustekinumab injection) to include the
treatment of pediatric individuals 6 years and older
with active psoriatic arthritis. Source: FDA website
|
Expanded Indication | 07-29-22 |
Rebinyn
The Food and Drug Administration (FDA)
approved Rebinyn® (coagulation factor IX, recombinant
injection) to include use in adults and children with
hemophilia B for routine prophylaxis to reduce the
frequency of bleeding episodes. Source: FDA website
|
Expanded Indication | 08-1-22 |
Tadliq
The Food and Drug Administration (FDA)
approved Tadliq® (tadalafil oral suspension) for the
treatment of pulmonary arterial hypertension (PAH) (WHO
Group 1) to improve exercise ability. Source: FDA
website
|
New Formulation | 06-17-22 |
Ultomiris
The Food and Drug Administration (FDA)
approved Ultomiris® (ravulizumab-cwvz subcutaneous
on-body injection) for the treatment of adults with
paroxysmal nocturnal hemoglobinuria (PNH) and atypical
hemolytic uremic syndrome (aHUS). Source: FDA website
|
New Formulation | 07-22-22 |
Kyzatrex
The Food and Drug Administration (FDA)
approved Kyzatrex® (testosterone undecanoate oral
capsules) for testosterone replacement therapy in adult
males for conditions associated with a deficiency or
absence of endogenous testosterone. Source: FDA website
|
New Formulation | 07-27-22 |
Zoryve
The Food and Drug Administration (FDA)
approved ZoryveTM (roflumilast topical) for topical
treatment of plaque psoriasis, including intertriginous
areas, in individuals 12 years of age and older. Source:
FDA website
|
New Formulation | 07-29-22 |
Magnesium citrate
Vi-Jon announced a voluntary recall
for all lots of all flavors of Magnesium citrate saline
laxative oral solution 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/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate
Source: FDA website
|
Drug Recall | 07-28-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with unresectable or metastatic
HER2-low (IHC 1+ or IHC 2+/ISH ) breast cancer who have
received a prior chemotherapy in the metastatic setting
or developed disease recurrence during or within six
months of completing adjuvant chemotherapy. Source: FDA
website
|
Expanded Indication | 08-05-22 |
Nubeqa
The Food and Drug Administration (FDA)
approved Nubeqa® (darolutamide tablets) in combination
with docetaxel for adults with metastatic
hormone-sensitive prostate cancer (mHSPC). Source: FDA
website
|
Expanded Indication | 08-05-22 |
Xofluza
The Food and Drug Administration (FDA)
approved Xofluza® (baloxavir marboxil tablets and oral
suspension) for the treatment of acute uncomplicated
influenza in otherwise healthy children aged five to
less than 12 years of age who have been symptomatic for
no more than 48 hours. Additionally, the FDA approved
Xofluza for the prevention (post-exposure prophylaxis)
of influenza in children aged five to less than 12 years
of age following contact with someone with influenza.
Source: FDA website
|
Expanded Indication | 08-11-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with unresectable or metastatic
non-small cell lung cancer (NSCLC) whose tumors have
activating human epidermal growth factor receptor 2 HER2
(ERBB2) mutations, as detected by a Food and Drug
Administration (FDA)-approved test, and who have
received a prior systemic therapy. Source: FDA website
|
New Indication | 08-11-22 |
Myfembree
The Food and Drug Administration (FDA)
approved Myfembree® (relugolix, estradiol, and
norethindrone acetate tablets) for the treatment of
endometriosis-associated pain. Source: FDA website
|
New Indication | 08-05-22 |
Calquence
The Food and Drug Administration (FDA)
approved Calquence® (acalabrutinib tablets) for adults
with chronic lymphocytic leukemia (CLL), small
lymphocytic lymphoma (SLL) and for individuals with
relapsed or refractory mantle cell lymphoma (MCL).
Source: FDA website
|
New Formulation | 08-03-22 |
Magnesium citrate
Vi-Jon expanded a voluntary recall of
all flavors and lots within expiry of magnesium citrate
saline laxative oral solution 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/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate
Source: FDA website
|
Drug Recall | 08-04-22 |
Milk of Magnesia and Magnesium
hydroxide/aluminum hydroxide/simethicone
Plastikon Healthcare expanded a
voluntary recall of Milk of Magnesia oral suspension and
Magnesium hydroxide/aluminum hydroxide/simethicone oral
suspension 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/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium
Source: FDA website
|
Drug Recall | 08-03-22 |
Auvelity
The Food and Drug Administration (FDA)
approved Auvelity (dextromethorphan hydrobromide and
bupropion hydrochloride
extended-release tablets) for the treatment of major
depressive disorder (MDD) in adults. Source: FDA website
|
New Formulation | 08-18-22 |
Zynteglo
The Food and Drug Administration (FDA)
approved Zynteglo® (betibeglogene autotemcel injection)
for the treatment of adult and pediatric individuals
with beta-thalassemia who require regular red blood cell
(RBC) transfusions. Source: FDA website
|
New Drug | 08-17-22 |
Takhzyro
The Food and Drug Administration (FDA)
approved Takhzyro® (lanadelumab-flyo injection) in
pediatric individuals 2 to < 12 years of age for
prophylaxis to prevent attacks of hereditary
angioedema (HAE). Source: FDA website
|
Expanded Indication | 2/3/2023 |
Synjardy and Synjardy XR
The Food and Drug Administration (FDA)
approved Synjardy® (empagliflozin/metformin tablets) and
Synjardy® XR (empagliflozin/metformin controlled-release
tablets) to include the reduction of risk for
cardiovascular death and hospitalization for heart
failure in adults with heart failure. Source: FDA
website
|
Expanded Indication | 2/6/2023 |
Cibinqo
The Food and Drug Administration (FDA)
approved Cibinqo™ (abrocitinib tablets) for pediatric
individuals 12 years of age and older with refractory,
moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with other systemic drug
products, including biologics, or when use of those
therapies is inadvisable. Source: FDA website
|
Expanded Indication | 2/9/2023 |
Eylea
The Food and Drug Administration (FDA)
approved Eylea® (aflibercept intravitreal injection) for
the treatment of preterm infants with retinopathy of
prematurity (ROP). Source: FDA website
|
New Indication | 2/8/2023 |
Glatiramer acetate autoinjector devices
The Food and Drug Administration (FDA)
is alerting consumers and healthcare providers that
autoinjector
devices that are optional for use with glatiramer
acetate injection may not be compatible for use across
FDA-approved
glatiramer acetate injection drug products. Contact your
healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector
Source: FDA website
|
Drug Warning | 08-18-22 |
Imbruvica
The Food and Drug Administration (FDA)
approved Imbruvica® (ibrutinib tablets, capsules, and
oral suspension) for pediatric individuals ≥ 1 year of
age with chronic graft versus host disease (cGVHD) after
failure of 1 or more lines of systemic therapy. Source:
FDA website
|
New Indication | 08-24-22 |
Pemazyre
The Food and Drug Administration (FDA)
approved PemazyreTM (pemigatinib tablets) for the
treatment of adults with relapsed or refractory
myeloid/lymphoid neoplasms or MLNs with fibroblast
growth factor receptor 1 (FGFR1) rearrangement. Source:
FDA website
|
New Indication | 08-26-22 |
Imfinzi
The Food and Drug Administration (FDA)
approved Imfinzi® (durvalumab injection) in combination
with gemcitabine and cisplatin for adults with locally
advanced or metastatic biliary tract cancer (BTC).
Source: FDA website
|
New Indication | 09-02-22 |
Orkambi
The Food and Drug Administration (FDA)
approved Orkambi® (ivacaftor/lumacaftor tablets and oral
granules) to include the treatment of cystic fibrosis
(CF) in individuals 1 to less than 2 years of age who
are homozygous for the F508del mutation in the cystic
fibrosis transmembrane conductance regulator (CFTR)
gene. Source: FDA website
|
Expanded Indication | 09-02-22 |
Konvomep
The Food and Drug Administration (FDA)
approved KonvomepTM (omeprazole/sodium bicarbonate oral
suspension) for short-term treatment (4 to 8 weeks) of
active benign gastric ulcer and reduction of risk of
upper gastrointestinal bleeding in critically ill
adults. Source: FDA website
|
New Formulation | 08-30-22 |
Xenpozyme
The Food and Drug Administration (FDA)
approved XenpozymeTM (olipudase alfa-rpcp injection) for
the treatment of non–central nervous system (CNS)
manifestations of acid sphingomyelinase deficiency
(ASMD) in adults and pediatrics. Source: FDA website
|
New Drug | 08-31-22 |
Spevigo
The Food and Drug Administration (FDA)
approved Spevigo® (spesolimab-sbzo injection) for the
treatment of generalized pustular psoriasis flares in
adults. Source: FDA website
|
New Drug | 09-01-22 |
Daxxify
The Food and Drug Administration (FDA) approved Daxxify® (daxibotulinumtoxinA-lanm) for the treatment of cervical dystonia in adults. Source: FDA website
|
New Indication | 8-10-2023 |
Akeega
The Food and Drug Administration (FDA) approved AkeegaTM (niraparib/abiraterone acetate tablets) for use with prednisone in adults with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. Source: FDA website
|
New Formulation | 8-11-2023 |
Hepzato Kit
The Food and Drug Administration (FDA) approved Hepzato Kit (melphalan for injection/hepatic delivery system) as a liver-directed treatment for adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Source: FDA website
|
New Formulation | 8-14-2023 |
Zurzuvae
The Food and Drug Administration (FDA) approved ZurzuvaeTM (zuranolone capsules) for the treatment of postpartum depression (PPD) in adults. Source: FDA website
|
New Drug | 8-4-2023 |
Izervay
The Food and Drug Administration (FDA) approved IzervayTM (avacincaptad pegol intravitreal injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Source: FDA website
|
New Drug | 8-4-2023 |
Talvey
The Food and Drug Administration (FDA) approved TalveyTM (talquetamab-tgvs injection) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 8-9-2023 |
Elrexfio
The Food and Drug Administration (FDA) approved ElrexfioTM (elranatamab-bcmm injection) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 8-14-2023 |
Sohonos
The Food and Drug Administration (FDA) approved SohonosTM (palovarotene capsules) for the reduction in volume of new heterotopic ossification in adults and pediatric individuals aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). Source: FDA website
|
New Drug | 8-16-2023 |
Terlivaz
The Food and Drug Administration (FDA)
approved Terlivaz® (terlipressin injection) to improve
kidney function in adults with hepatorenal syndrome with
rapid reduction in kidney function. Source: FDA website
|
New Drug | 09-14-22 |
Rolvedon
The Food and Drug Administration (FDA)
approved RolvedonTM (eflapegrastim-xnst injection) to
decrease the incidence of
infection, as manifested by febrile neutropenia, in
adults with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with
clinically significant incidence of febrile neutropenia.
Source: FDA website
|
New Drug | 09-09-22 |
Sotyktu
The Food and Drug Administration (FDA)
approved SotyktuTM (deucravacitinib oral tablets) for
the treatment
of adults with moderate-to-severe plaque psoriasis who
are candidates for systemic therapy or phototherapy.
Source: FDA website
|
New Drug | 09-09-22 |
Retevmo
The Food and Drug Administration (FDA)
approved Retevmo® (selpercatinib capsules)
for adults with locally advanced or metastatic solid
tumors with a rearranged
during transfection (RET) gene fusion. Source: FDA
website
|
New Indication | 09-21-22 |
Aponvie
The Food and Drug Administration (FDA)
approved Aponvie™ (aprepitant injection)
for the prevention of postoperative nausea and vomiting
in adults. Source: FDA website
|
New Formulation | 09-16-22 |
Pedmark
The Food and Drug Administration (FDA)
approved Pedmark™ (sodium thiosulfate injection)
for the reduction of ototoxicity risk associated with
cisplatin in individuals 1 month of age
and older with localized, non-metastatic solid tumors.
Source: FDA website
|
New Drug | 09-20-22 |
Skysona
The Food and Drug Administration (FDA)
approved Skysona® (elivaldogene autotemcel
injection)
to slow the progression of neurologic dysfunction in
boys 4-17 years of age with early, active
cerebral adrenoleukodystrophy (CALD). Early, active CALD
refers to asymptomatic or
mildly symptomatic (neurologic function score, NFS ≤ 1)
boys who have gadolinium enhancement on brain magnetic
resonance imaging (MRI) and Loess scores of 0.5-9.
Source: FDA website
|
New Drug | 09-16-22 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection) for the
treatment of adults with prurigo nodularis. Source: FDA
website
|
New Indication | 09-28-22 |
Firdapse
The Food and Drug Administration (FDA)
approved Firdapse® (amifampridine tablets) to expand the
indicated age range to include pediatric individuals six
years of age and older for the treatment of
Lambert-Eaton myasthenic syndrome (LEMS).Source: FDA
website
|
Expanded Indication | 09-29-22 |
Relyvrio
The Food and Drug Administration (FDA)
approved Relyvrio (sodium phenylbutyrate and
taurursodiol for oral suspension) for the treatment of
amyotrophic lateral sclerosis (ALS) in adults. Source:
FDA website
|
New Drug | 09-29-22 |
Omlonti
The Food and Drug Administration (FDA)
approved Omlonti® (omidenepag isopropyl ophthalmic
solution) for the reduction of elevated intraocular
pressure in individuals with primary open-angle glaucoma
or ocular hypertension. Source: FDA website
|
New Drug | 09-22-22 |
Golden State Medical Supply
Golden State Medical Supply announced
a voluntary recall of one lot of clopidogrel 75 mg
tablets due to being mislabeled as atenolol 25 mg
tablets. 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-atenolol-25-mg-tablets-and
Source: FDA website
|
Drug Recall | 09-30-22 |
Acyclovir sodium
Eugia US LLC announced a voluntary
recall of one lot of AuroMedics acyclovir sodium
injection 500 mg per 10 mL 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/eugia-us-llc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-500-mg-10-ml-50-mgml-due
Source: FDA website
|
Drug Recall | 09-27-22 |
Oxlumo
The Food and Drug Administration (FDA)
approved Oxlumo® (lumasiran injection) to include
treatment of individuals with advanced primary
hyperoxaluria type 1 (PH1). Source: FDA website
|
Expanded Indication | 06-10-22 |
Boostrix
The Food and Drug Administration (FDA)
approved Boostrix® (tetanus toxoid, reduced diphtheria
toxoid and acellular pertussis vaccine, adsorbed
injection) for immunization expansion during the third
trimester of pregnancy to prevent pertussis in infants
younger than two months of age. Source: FDA website
|
Expanded Indication | 07-10-22 |
Lyumjev
The Food and Drug Administration (FDA)
approved Lyumjev® (insulin lispro-aabc injection) to
improve glycemic control in pediatric individuals with
diabetes mellitus. Source: FDA website
|
Expanded Indication | 14-10-22 |
Furoscix
The Food and Drug Administration (FDA)
approved Furoscix® (furosemide injection for
subcutaneous use) delivered by an on-body infusor
approved for the treatment of congestion due to fluid
overload in adults with NYHA Class II/III chronic heart
failure. Source: FDA website
|
New Formulation | 07-10-22 |