Drug Information

View drug alerts Information in California, Georgia, 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
Kerydin
The Food and Drug Administration (FDA) approved KerydinTM (tavaborole topical solution) for the treatment of toenail fungus. Source: FDA website
New Drug 07-07-14
Zydelig
The Food and Drug Administration (FDA) approved Zydelig® (idelalisib tablets) in combination with rituximab for individuals with relapsed chronic lymphocytic leukemia (CLL) for whom rituxumab alone would be considered appropriate therapy, as monotherapy for individuals with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior therapies and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. Source: FDA website
New Drug 07-23-14
Ruconest
The Food and Drug Administration (FDA) approved Ruconest® (C1 esterase inhibitor injection) for the treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Source: FDA website
New Drug 07-17-14
Acticlate
The Food and Drug Administration (FDA) approved ActiclateTM (doxycycline hyclate tablets) for the treatment of susceptible infections including adjunctive therapy in severe acne. Source: FDA website
New Drug 07-25-14
Rasuvo
The Food and Drug Administration (FDA) approved RasuvoTM (methotrexate subcutaneous auto-injection) for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis. Source: FDA website
New Drug 07-14-14
Octagam 10%
The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin intravenous injection) for the treatment of adults with chronic immune thrombocytopenic purpura (ITP). Source: FDA website
New Indication 07-15-14
Ryanodex
The Food and Drug Administration (FDA) approved Ryanodex® (dantrolene sodium injection) for the treatment of malignant hyperthermia (MH), along with appropriate supportive measures. Source: FDA website
New Drug 07-23-14
Targiniq ER
The Food and Drug Administration (FDA) approved TarginiqTM ER (oxycodone/naloxone tablets) for the treatment of severe pain. Source: FDA website
New Drug 07-24-14
NovoSeven RT
The Food and Drug Administration (FDA) approved NovoSeven® RT (coagulation factor VIIa, recombinant injection) for the treatment of bleeding episodes and perioperative management in individuals with Glanzmann's Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets. Source: FDA website
New Indication 07-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) for the treatment of individuals with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion). Source: FDA website
New Indication 07-28-14
Mekinist and Tafinlar
The Food and Drug Administration approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) for combination use in unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Source: FDA website
New Indications 01-09-14
Isentress
The Food and Drug Administration (FDA) approved Isentress® (raltegravir oral suspension) for the treatment of human immunodeficiency virus (HIV)-1 infection in pediatric patients. Source: FDA website
New Drug 01-08-14
Farxiga
The Food and Drug Administration (FDA) approved FarxigaTM (dapagliflozin tablets) to improve glycemic control, with diet and exercise, in adults with type 2 diabetes. Source: FDA website
New Drug 01-08-14
TRUEtrack and TRUEbalance blood glucose meters
Nipro Diagnostics announced a voluntary recall of a limited number of TRUEbalance® and TRUEtrack® blood glucose meters due an incorrect factory-set unit of measure. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380758.htm Source: FDA website
Drug Warnings 01-08-14
Sodium Phosphate over-the-counter products
The Food and Drug Administration (FDA) is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and possible death. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380833.htm Source: FDA website
Drug Warnings 01-08-14
Pennsaid
The Food and Drug Administration (FDA) approved Pennsaid® (diclofenac sodium 2% topical solution) for the treatment of osteoarthritis pain of the knee. Source: FDA website
New Drug 01-17-14
Copaxone
The Food and Drug Administration (FDA) approved Copaxone® (glatiramer acetate 40 mg injection) for the treatment of multiple sclerosis. This new formulation can be administered three times a week. Source: FDA website
New Drug 01-28-14
Hetlioz
The Food and Drug Administration (FDA) approved HetliozTM (tasimelteon capsules) for the treatment of non-24-hour sleep-wake disorder (non-24) in blind individuals. Source: FDA website
New Drug 01-31-14
t:slim Insulin Cartridges
Tandem Diabetes Care announced a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump due to a risk for leaking. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381606.htm Source: FDA website
Drug Recall 01-14-14
Acetaminophen Prescription Combination Drug Products
The Food and Drug Administration (FDA) recommended that health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per dosage unit due to the potential for liver injury. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm381650.htm Source: FDA website
Drug Warning 01-14-14
Calcium gluconate
The Food and Drug Administration (FDA) notified healthcare professionals to follow up with individuals who received calcium gluconate 10% injections made by Rx Formulations in Mesa, AZ between November 7, 2013 and December 11, 2013. FDA testing confirmed the presence of microbial contamination in one lot of calcium gluconate product. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm Source: FDA website
Drug Warning 02-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) as a single agent for individuals with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Source: FDA website
New Indications 02-12-14
Kalydeco
The Food and Drug Administration (FDA) approved KalydecoTM (ivacaftor tablets) for use in individuals with cystic fibrosis (CF) ages 6 years older who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indications 02-21-14
Vimizim
The Food and Drug Administration (FDA) approved VimizimTM (elosulfase alfa injection) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Source: FDA website
New Drug 02-14-14
Northera
The Food and Drug Administration (FDA) approved NortheraTM (droxidopa capsules) for the treatment of symptomatic neurogenic orthostatic hypotension. Source: FDA website
New Drug 02-18-14
Tivorbex
The Food and Drug Administration (FDA) approved TivorbexTM (indomethacin capsules) for the treatment of mild-to-moderate acute pain in adults. Source: FDA website
New Drug 02-24-14
Myalept
The Food and Drug Administration (FDA) approved MyaleptTM (metreleptin injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in individuals with congenital generalized or acquired generalized lipodystrophy. Source: FDA website
New Drug 02-24-14
Bydureon Pen
The Food and Drug Administration (FDA) approved Bydureon® Pen (exenatide extended-release for injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug 03-03-14
Aveed
The Food and Drug Administration (FDA) approved AveedTM (testosterone undecanoate injection) as a testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism in adult males. Source: FDA website
New Drug 03-06-14
Xartemis XR
The Food and Drug Administration (FDA) approved XartemisTM XR (oxycodone/acetaminophen extended-release tablets) for the management of acute pain severe enough to require opioid treatment and in individuals for whom alternative options are ineffective, not tolerated or would otherwise be inadequate. Source: FDA website
New Drug 03-12-14
Qudexy XR
The Food and Drug Administration (FDA) approved QudexyTM XR (topiramate extended-release capsules) as initial monotherapy in individuals greater than 10 years of age with partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR is also approved as adjunct therapy in individuals greater than 2 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Source: FDA website
New Drug 03-12-14
Effexor XR 150 mg and Venlafaxine XR 150 mg
Pfizer announced a recall on one lot of 30-count Effexor XR® 150 mg extended-release capsules, one lot of 90-count Effexor XR 150 mg extended-release capsules, and one lot of 90-count Greenstone branded Venlafaxine 150 mg extended-release capsules. The recall is due to a report that one bottle of Effexor XR contained one capsule of Tikosyn® (dofetilide). Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm Source: FDA website
Drug Recall 03-07-14
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in individuals who have undergone hip or knee replacement surgery. Source: FDA website
New Indications 03-14-14
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) for the treatment of chronic idiopathic urticaria (CIU) in individuals greater than 12 years of age who remain asymptomatic despite H1-antihistamine therapy. Source: FDA website
New Indications 03-21-14
Impavido
The Food and Drug Administration (FDA) approved Impavido® (miltefosine capsules) in adults and adolescents for the treatment of visceral leishmaniasis, cutaneous leishmaniasis, and, mucosal leishmaniasis. Source: FDA website
New Drug 03-19-14
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of psoriatic arthritis. Source: FDA website
New Drug 03-21-14
Noxafil
The Food and Drug Administration (FDA) approved Noxafil® (posaconazole injection) for prophylaxis against invasive Aspergillus and Candida infections, in individuals at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft vs. host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia due to chemotherapy. Source: FDA website
New Drug03-14-14
Hemangeol
The Food and Drug Administration (FDA) approved HemangeolTM (propranolol oral solution) for the treatment of proliferating infantile hemangioma requiring systemic therapy. Source: FDA website
New Drug 03-17-14
Metronidazole Vaginal Gel 1.3%
The Food and Drug Administration (FDA) approved Metronidazole Vaginal Gel 1.3% for the treatment of bacterial vaginosis. Source: FDA website
New Drug03-26-14
Adacel
The Food and Drug Administration (FDA) approved Adacel® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; adsorbed injection) to immunize against tetanus, diphtheria, and pertussis in children as young as 10 years old. Source: FDA website
New Indications04-01-14
Alli
GlaxoSmithKline and Consumer Healthcare announced a recall of all AlliTM (orlistat capsules) weight loss products due to the possibility of product tampering. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391013.htm Source: FDA website
Drug Recall03-28-14
Alprolix
The Food and Drug Administration (FDA) approved AlprolixTM (coagulation Factor IX recombinant, Fc fusion protein injection) to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia B. Source: FDA website
New Drug03-28-14
Evzio
The Food and Drug Administration (FDA) approved EvzioTM (naloxone injection) for the emergency treatment of opioid overdose. Source: FDA website
New Drug04-03-14
Kalbitor
The Food and Drug Administration (FDA) approved Kalbitor® (ecallantide injection) for the treatment of acute attacks of hereditary angioedema (HAE) in individuals greater than 12 years old. Source: FDA website
New Indications04-03-14
Oralair
The Food and Drug Administration (FDA) approved Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract sublingual tablet) for the treatment of allergic rhinitis with or without conjunctivitis caused by certain grass pollens in individuals aged 10 to 65 years. Source: FDA website
New Drug04-02-14
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate capsules) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in individuals who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients. Source: FDA website
New Indications04-07-14
Topamax
The Food and Drug Administration (FDA) approved Topamax® (topiramate tablets) for prevention of migraines in adolescents aged 12-17 years old. Source: FDA website
New Indications03-28-14
Grastek
The Food and Drug Administration (FDA) approved Grastek® (Timothy grass pollen allergen extract sublingual tablet) for the treatment of grass-pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 5 to 65 years. Source: FDA website
New Drug04-15-14
Ragwitek
The Food and Drug Administration (FDA) approved RagwitekTM (short ragweed pollen allergen extract sublingual tablet) for the treatment of short ragweed pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 18 to 65 years. Source: FDA website
New Drug04-17-14
Tanzeum
The Food and Drug Administration (FDA) approved TanzeumTM (albiglutide subcutaneous injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug04-15-14
Cyramza
The Food and Drug Administration (FDA) approved CyramzaTM(ramucirumab injection) for the treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine- or platinum-containing chemotherapy. Source: FDA website
New Drug04-21-14
Sylvant
The Food and Drug Administration (FDA) approved SylvantTM (siltuximab injection) for the treatment of multicentric Castleman's disease (MCD). Source: FDA website
New Drug04-23-14
Arzerra
The Food and Drug Administration (FDA) approved Arzerra® (ofatumumab injection) for use in combination with chlorambucil for the treatment of previously untreated individuals with chronic lymphocytic leukemia (CLL) for whom, fludarabine-based therapy is considered inappropriate. Source: FDA website
New Indications04-17-14
Cubicin
Cubist Pharmaceuticals announced a recall of one lot of Cubicin® (daptomycin 500 mg injection) due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394025.htm Source: FDA website
Drug Warning04-18-14
Lidocaine
Hospira announced a recall of one lot of Lidocaine 1%, 10 mg/mL, 30 mL single dose, preservative-free vials due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394026.htm Source: FDA website
Drug Warning04-19-14
Purixan
The Food and Drug Administration (FDA) approved PurixanTM (mercaptopurine oral suspension) for the treatment of individuals with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Source: FDA website
New Drug04-29-14
Zykadia
The Food and Drug Administration (FDA) approved ZykadiaTM (ceritinib capsules) for individuals with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug04-29-14
Incruse Ellipta
The Food and Drug Administration (FDA) approved IncruseTM Ellipta® (umeclidinium oral inhaler) for the long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug04-30-14
Epanova
The Food and Drug Administration (FDA) approved EpanovaTM(omega-3-carboxylic acids capsules) as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (>500 mg/dL). Source: FDA website
New Drug05-06-14
Zontivity
The Food and Drug Administration (FDA) approved ZontivityTM (vorapaxar tablets) to reduce the risk of heart attack, stroke, cardiovascular death, and need for coronary revascularization in individuals with a previous heart attack or blockages in the arteries to the legs. Source: FDA website
New Drug05-08-14
Kogenate FS
The Food and Drug Administration (FDA) approved Kogenate FS® (antihemophilic factor VIII, recombinant injection) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Source: FDA website
New Indications05-12-14
GenStrip Blood Glucose Test Strips
The Food and Drug Administration (FDA) has advised consumers and health care professionals to stop using GenStrip Blood Glucose Test Strips by Shasta Technologies because the strips may report incorrect blood glucose levels. The FDA recommends the use of alternative glucose test strips designed for use with the LifeScan OneTouch family of glucose meters. Contact your health care professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm Source: FDA website
Drug Warning04-29-14
Entyvio
The Food and Drug Administration (FDA) approved Entyvio® (vedolizumab injection) for the treatment of adults with moderate to severe ulcerative colitis and Crohn's disease. Source: FDA website
New Drug05-19-14
Dalvance
The Food and Drug Administration (FDA) approved Dalvance™ (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). Source: FDA website
New Drug05-23-14
Natesto
The Food and Drug Administration (FDA) approved Natesto™ (testosterone nasal gel) for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Source: FDA website
New Drug05-29-14
Vectibix
The Food and Drug Administration (FDA) approved Vectibix® (panitumumab injection) for use in combination with FOLFOX chemotherapy as a first-line treatment in individuals with wild-type KRAS (exon 2) metastatic colorectal cancer. A companion diagnostic test was also approved. Source: FDA website
New Indications05-27-14
Aloxi
The Food and Drug Administration (FDA) approved Aloxi® (palonosetron injection) for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in children aged 1 month to < 17 years. Source: FDA website
New Indications05-28-14
Lunesta
The Food and Drug Administration (FDA) announced a warning that the insomnia drug Lunesta® (eszopiclone tablets) and its generics may cause next-day impairment of driving and other activities that require alertness. The agency recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397536.htm Source: FDA website
Drug Warning05-15-14
Pradaxa
The Food and Drug Administration (FDA) completed a study comparing Pradaxa® (dabigatran capsules) to warfarin and found that Pradaxa was associated with a lower risk for stroke and death but a higher risk for gastrointestinal bleeding compared with warfarin. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm Source: FDA website
Drug Warning05-13-14
Labetalol
Hospira announced a recall of one lot of Labetalol Hydrochloride Injection 100 mg/20 mL multidose vial due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397775.htm Source: FDA website
Drug Recall05-16-14
Vogelxo
The Food and Drug Administration (FDA) approved Vogelxo™ (testosterone topical gel) for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Source: FDA website
New Drug06-04-14
Jublia
The Food and Drug Administration (FDA) approved Jublia® (efinaconazole topical solution) for the treatment of onychomycosis of the toenails. Source: FDA website
New Drug06-09-14
Eloctate
The Food and Drug Administration (FDA) approved Eloctate™ (coagulation factor VIII recombinant, Fc fusion protein injection) for use in adults and children with hemophilia A. Source: FDA website
New Drug06-09-14
Bunavail
The Food and Drug Administration (FDA) approved Bunavail™ (buprenorphine/naloxone buccal film) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug06-09-14
Nascobal
The Food and Drug Administration (FDA) approved Nascobal® (cyanocobalamin nasal spray) single-use disposable device for the maintenance of normal hematologic status in pernicious anemia and for other vitamin B12 deficiencies. Source: FDA website
New Drug06-10-14
Azilect
The Food and Drug Administration (FDA) approved Azilect® (rasagiline tablets) for the expanded indication of adjunct treatment to dopamine agonists in Parkinson's disease. Source: FDA website
New Indication06-09-14
Advocate Redi-Code+
Diabetic Supply of Suncoast announced a voluntary recall of all Advocate Redi-Code+ blood glucose test strips manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the test strips are designed to be used with. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm Source: FDA website
Drug Recall06-11-14
Sivextro
The Food and Drug Administration (FDA) approved SivextroTM (tedizolid tablet and injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA). Source: FDA website
New Drug06-23-14
Afrezza
The Food and Drug Administration (FDA) approved Afrezza® (human insulin injection) for the improvement of glycemic control in adults with diabetes mellitus. Source: FDA website
New Drug06-30-14
Beleodaq
The Food and Drug Administration (FDA) approved BeleodaqTM (belinostat injection) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Source: FDA website
New Drug07-03-14
Ozurdex
The Food and Drug Administration (FDA) approved Ozurdex® (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in adults who have an artificial lens implant or who are scheduled for cataract surgery. Source: FDA website
New Indications07-01-14
Lidocaine Viscous
The Food and Drug Administration (FDA) announced that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. The agency is requiring a Boxed Warning to be added to labeling. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm Source: FDA website
Drug Warning06-26-14
Over-the-Counter Topical Acne Products
The Food and Drug Administration (FDA) announced that certain over-the-counter (OTC) topical acne products may cause rare but serious potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv®, Neutrogena®, MaxClarity™, Oxy™, Ambi®, Aveeno®, Clean & Clear®, and as store brands. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm Source: FDA website
Drug Warning06-25-14
Coumadin
Bristol-Myers Squibb announced a voluntary recall of six lots of Coumadin®, (warfarin injection) 5 mg single-use vials due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403583.htm Source: FDA website.
Drug Recall07-01-14
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of diabetic macular edema (DME). Source: FDA website.
New Indication 07-30-14
Lumizyme
The Food and Drug Administration (FDA) approved LumizymeTM(alglucosidase alfa injection) for the treatment of individuals with infantile-onset Pompe disease, including individuals who are < 8 years old. Source: FDA website.
New Indication 08-01-14
Striverdi Respimat
The Food and Drug Administration (FDA) approved Striverdi® Respimat® (olodaterol oral inhalation) for the treatment of individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema with airflow obstruction. Source: FDA website.
New Drug 07-31-14
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website.
New Drug 08-01-14
Orbactiv
The Food and Drug Administration (FDA) approved OrbactivTM(oritavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible designated Gram-positive bacteria. Source: FDA website.
New Drug 08-07-14
Lidocaine Injection
Hospira announced a recall of one lot of Lidocaine injection 2%, 20 mg/mL, 5 mL preservative-free, single-dose vial due to a report of discolored product with visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm407249.htm Source: FDA website.
Drug Recall 07-30-14
RegenESlim Appetite Control
Regeneca Worldwide announced a recall of RegenESlim Appetite Control dietary supplement due to the presence of DMAA. The Food and Drug Administration (FDA) has warned that 1,3-dimethylamylamine (DMAA) can cause potentially dangerous cardiovascular problems. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408681.htm Source: FDA website.
Drug Recall 08-07-14
Velcade
The Food and Drug Administration (FDA) approved Velcade® (bortezomib injection) for the retreatment of adults with multiple myeloma who had previously reponded to Velcade therapy and relapsed at least six months following completion. Source: FDA website
New Indication 08-10-14
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent, or metastatic cervical cancer. Source: FDA website
New Indication 08-15-14
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. Source: FDA website
New Indication 08-21-14
Invokamet
The Food and Drug Administration (FDA) approved InvokametTM (canagliflozin/metformin tablets) for the treatment of adults with type 2 diabetes. Source: FDA website
New Drug 08-11-14
Belsomra
The Food and Drug Administration (FDA) approved Belsomra® (suvorexant tablets) for the treatment of insomnia. Source: FDA website
New Drug 08-13-14
Nutrilipid
The Food and Drug Administration (FDA) approved Nutrilipid® (20% fat emulsion injection) for parenteral nutrition therapy in adults and pediatric individuals. Source: FDA website
New Drug 08-13-14
Plegridy
The Food and Drug Administration (FDA) approved PlegridyTM (peginterferon beta-1a injection) for the treatment of relapsing forms of multiple sclerosis. Source: FDA website
New Drug 08-15-14
Cerdelga
The Food and Drug Administration (FDA) approved CerdelgaTM (eliglustat capsules) for the treatment of certain adults with Gaucher disease type 1 disease. Source: FDA website
New Drug 08-19-14
Arnuity Ellipta
The Food and Drug Administration (FDA) approved ArnuityTM Ellipta® (fluticasone furoate oral inhalation powder) for the maintenance treatment of asthma as prophylactic therapy in individuals 12 years old or greater. Source: FDA website
New Drug 08-20-14
Afluria PharmaJet Stratis
The Food and Drug Administration (FDA) approved Afluria® PharmaJet Stratis® 0.5 mL Needle-Free Jet Injector (trivalent influenza vaccine injection) for influenza vaccination in individuals aged 18-64 years. Source: FDA website
New Drug 08-19-14
Zorvolex
The Food and Drug Administration (FDA) approved Zorvolex® (diclofenac capsules) for the management of osteoarthritis pain. Source: FDA website
New Drug 08-25-14
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) in individuals with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Source: FDA website
New Indication 08-26-14
Elelyso
The Food and Drug Administration (FDA) approved ElelysoTM (taliglucerase alfa injection) for long-term enzyme replacement therapy (ERT) in pediatric individuals with a confirmed diagnosis of Type 1 Gaucher disease. Source: FDA website
New Indication 08-28-14
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablets, injection, and oral solution) as monotherapy in the treatment of partial-onset seizures in individuals with epilepsy aged > 17 years. Source: FDA website
New Indication 09-02-14
Epaned
The Food and Drug Administration (FDA) approved EpanedTM (enalapril maleate powder for oral solution) for treatment of symptomatic heart failure and treatment of asymptomatic left ventricular dysfunction. Source: FDA website
New Indication 09-08-14
Menactra
The Food and Drug Administration (FDA) approved Menactra® (meningococcal Groups A, C, Y, W-135 polysaccharide diphtheria toxoid conjugate vaccine injection) for booster vaccination against meningococcal disease in individuals aged 15-55 years. Source: FDA website
New Indication 09-08-14
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) in metastatic castration-resistant prostate cancer (CRPC) in men who have not yet received chemotherapy. Source: FDA website
New Indication 09-10-14
Triumeq
The Food and Drug Administration (FDA) approved Triumeq® (abacavir/dolutegravir/lamivudine tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 08-22-14
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of advanced or unresectable melanoma in individuals who are no longer responsive to other drugs. Source: FDA websitee
New Drug 09-04-14
Ferric Citrate
The Food and Drug Administration (FDA) approved Ferric Citrate for the control of serum phosphorus levels in individuals with chronic kidney disease on dialysis. A brand name is still to be determined. Source: FDA website
New Drug 09-05-14
Contrave
The Food and Drug Administration (FDA) approved Contrave® (naltrexone/bupropion extended-release tablets) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) > 30 kg/m2 (obese) or > 27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition. Source: FDA website
New Drug 09-11-14
Martin Avenue Pharmacy
Martin Avenue Pharmacy announced a voluntary recall of all in-date compounded sterile preparations due to a lack of assurance of sterility. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm412493.htm Source: FDA website
Drug Recall 09-02-14
Pharmacy Creations
Pharmacy Creations announced a voluntary recall of four lots of products due to potential non-sterility. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm413053.htm Source: FDA website
Drug Recall 09-06-14
Rixubis
The Food and Drug Administration (FDA) approved Rixubis® (coagulation factor IX [recombinant] injection) for routine prophylaxis, control, and prevention of bleeding episodes, and perioperative management in children with hemophilia B. Source: FDA website
New Indication 09-15-14
Stendra
The Food and Drug Administration (FDA) approved Stendra® (avanafil tablets) to be taken as early as approximately 15 minutes before sexual activity in the treatment of erectile dysfunction. Source: FDA website
New Indication 09-18-14
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of individuals with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Source: FDA website
New Indication 09-23-14
Minivelle
The Food and Drug Administration (FDA) approved Minivelle® (estradiol 0.025 mg/day patch) for the prevention of postmenopausal osteoporosis. Source: FDA website
New Indication 09-24-14
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for reducing signs and symptoms, and achieving and maintaining clinical remission, in Crohn's disease for individuals 6 years old or greater when certain other treatments were inadequate. Source: FDA website
New Indication 09-25-14
HyQvia
The Food and Drug Administration (FDA) approved HyQvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase injection) for adults with primary immunodeficiency (PI). Source: FDA website
New Drug 09-15-14
Spiriva Respimat
The Food and Drug Administration (FDA) approved Spiriva® Respimat® (tiotropium bromide oral inhalation spray) for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Source: FDA website
New Drug 09-15-14
Movantik
The Food and Drug Administration (FDA) approved MovantikTM (naloxegol tablets) for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Source: FDA website
New Drug 09-16-14
Trulicity
The Food and Drug Administration (FDA) approved TrulicityTM (dulaglutide injection) to improve blood sugar control in adults with type 2 diabetes. Source: FDA website
New Drug 09-18-14
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) to increase systemic exposure of atazanavir or darunavir in combination with other antiretroviral agents in the treatment of human immunodeficiency virus-1 (HIV-1) infection. Source: FDA website
New Drug 09-24-14
Vitekta
The Food and Drug Administration (FDA) approved Vitekta® (elvitegravir tablets) in combination with a ritonavir-boosted protease inhibitor and with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults. Source: FDA website
New Drug 09-24-14
Taclonex Topical Suspension
The Food and Drug Administration (FDA) approved Taclonex® (calcipotriene/betamethasone dipropionate) Topical Suspension for the treatment of plaque psoriasis of the scalp in individuals aged 12-17 years. Source: FDA website
New Indication 09-30-14
Ozurdex
The Food and Drug Administration (FDA) approved Ozurdex® (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in the general DME population. Source: FDA website
New Indication 09-29-14
Relistor
The Food and Drug Administration (FDA) approved Relistor® (methylnaltrexone bromide injection) for the treatment of opioid induced constipation in chronic pain unrelated to cancer. Source: FDA website
New Indication 09-29-14
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years and older. Source: FDA website
New Indication 10-06-14
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of macular edema following retinal vein occlusion (RVO), including macular edema following branch retinal vein occlusion (BRVO) in addition to macular edema following central retinal vein occlusion (CRVO). Source: FDA website
New Indication 10-07-14
Velcade
The Food and Drug Administration (FDA) approved Velcade® (bortezomib injection) for the treatment of mantle cell lymphoma (MCL) in previously untreated patients. Source: FDA website
New Indication 10-09-14
Xiaflex
The Food and Drug Administration (FDA) approved Xiaflex® (collagenase clostridium histolyticum injection) for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. Source: FDA website
New Indication 10-21-14
Flublok
The Food and Drug Administration (FDA) approved Flublok® (trivalent recombinant influenza vaccine injection) for use in all adults aged 18 and older for active immunization against influenza virus subtypes A and B. Source: FDA website
New Indication 10-29-14
Embeda
The Food and Drug Administration (FDA) approved labeling for Embeda® (morphine sulfate/naltrexone extended-release capsules) to include abuse-deterrence studies. Embeda is indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda was withdrawn from the market in March 2011 due to manufacturing issues. It will be re-introduced in early 2015. Source: FDA website
New Drug 10-20-14
Abilify Maintena
The Food and Drug Administration (FDA) approved Abilify Maintena® (aripiprazole extended-release injection) as a prefilled dual-chamber syringe for the treatment of schizophrenia. Source: FDA website
New Drug09-30-14
Iluvien
The Food and Drug Administration (FDA) approved Iluvien® (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME) in individuals who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Source: FDA website
New Drug 09-29-14
Mitigare
The Food and Drug Administration (FDA) approved MitigareTM (colchicine capsules) for the prophylaxis of gout flares in adults. Source: FDA website
New Drug 09-30-14
Prepopik
The Food and Drug Administration (FDA) approved Prepopik® (sodium picosulfate/magnesium oxide/anhydrous citric acid) in a new cranberry flavor for cleansing of the colon as a preparation for colonoscopy in adults. Source: FDA website
New Drug 10-07-14
Uceris Rectal Foam
The Food and Drug Administration (FDA) approved Uceris® (budesonide rectal foam) for the induction of remission in individuals with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge. Source: FDA website
New Drug 10-08-14
Sotylize
The Food and Drug Administration (FDA) approved SotylizeTM(sotalol oral solution) for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in individuals with a history of symptomatic atrial fibrillation/flutter. Source: FDA website
New Drug 10-23-14
Obizur
The Food and Drug Administration (FDA) approved ObizurTM (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A. Source: FDA website
New Drug 10-24-14
Trumenba
The Food and Drug Administration (FDA) approved Trumenba® (meningococcal vaccine group B injection) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years. Source: FDA website
New Drug 10-29-14
Xigduo XR
The Food and Drug Administration (FDA) approved XidguoTM XR (dapagliflozin/metformin tablets) as adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. Source: FDA website
New Drug 10-30-14
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (netupitant/palonosetron capsules) for the prevention of chemotherapy-induced nausea and vomiting. Source: FDA website
New Drug 10-10-14
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) for the treatment of chronic hepatitis C genotype 1 infection in adults. Source: FDA website
New Drug 10-10-14
Esbriet
The Food and Drug Administration (FDA) approved Esbriet® (pirfenidone capsules) for the treatment of idiopathic pulmonary fibrosis. Source: FDA website
New Drug 10-15-14
Ofev
The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) for the treatment of idiopathic pulmonary fibrosis. Source: FDA website
New Drug 10-15-14
Naproxen sodium
Contract Packaging Resources announced a voluntary recall of Assured brand Naproxen sodium tablets due to some cartons containing bottles of ibuprofen, a different pain reliever. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419769.htm Source: FDA website
Drug Recall 10-22-14
Lidocaine
Hospira announced a voluntary recall of one lot of 1% Lidocaine HCL injection 10 mg/mL, 30 mL single-dose, preservative-free vials due to report of particulate in a single unit. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419322.htm Source: FDA website
Drug Recall 10-17-14
Cyramza
The Food and Drug Administration (FDA) approved CyramzaTM (ramucirumab injection) for use in combination with paclitaxel for the treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Source: FDA website
New Indication 11-05-14
Olysio and Sovaldi
The Food and Drug Administration (FDA) approved Olysio® (simeprevir capsules) for use in combination with Sovaldi® (sofosbuvir tablets) for once-daily treatment in individuals with hepatitis C genotype 1. Source: FDA website
New Indication 11-06-14
Invega Sustenna
The Food and Drug Administration (FDA) approved Invega® Sustenna® (paliperidone palmitate injection) as either monotherapy or adjunctive therapy in the once-monthly treatment of schizoaffective disorder. Source: FDA website
New Indication 11-13-14
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. Source: FDA website
New Indication 11-14-14
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) as a prefilled, low-volume syringe that supports full-dose delivery with no reconstitution needed for the treatment of acromegaly. Source: FDA website
New Drug 11-06-14
Vasostrict
The Food and Drug Administration (FDA) approved VasostrictTM (vasopressin injection) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. This is the first vasopressin injection product to receive an approval from the FDA. Source: FDA website
New Drug 11-12-14
Lemtrada
The Food and Drug Administration (FDA) approved LemtradaTM (alemtuzumab injection) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website.
New Drug 11-17-14
Hysingla ER
The Food and Drug Administration (FDA) approved HysinglaTM ER (hydrocodone extended-release tablets) for the treatment of severe pain that requires daily long-term opioid treatment and for which other treatment options are inadequate. Source: FDA website
New Drug 11-20-14
Onexton
The Food and Drug Administration (FDA) approved OnextonTM (clindamycin phosphate/benzoyl peroxide gel) for the once-daily treatment of comedonal and inflammatory acne in individuals ages 12 years and older. Source: FDA website
New Drug 11-25-14
Kitabis Pak (tobramycin inhalation solution and nebulizer)
The Food and Drug Administration (FDA) approved KitabisTM Pak (tobramycin inhalation solution and nebulizer) approved for individuals with cystic fibrosis ages 6 years and older with Pseudomonas aeruginosa. Source: FDA website
New Drug 12-03-14
Trezix
The Food and Drug Administration (FDA) approved TrezixTM (acetaminophen/caffeine/dihydrocodeine bitartrate capsules) for the management of moderate to moderately severe pain. Source: FDA website
New Drug 12-05-14
Blincyto
The Food and Drug Administration (FDA) approved BlincytoTM (blinatumomab injection) for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Source: FDA website
New Drug 12-03-14
Jakafi
The Food and Drug Administration (FDA) approved Jakafi®(ruxolitinib tablets) for the treatment of polycythemia vera (PV) in individuals who have had an inadequate response to or are intolerant of hydroxyurea. Source: FDA website
New Indication 12-04-14
Priftin
The Food and Drug Administration (FDA) approved Priftin® (rifapentine tablets) in combination with isoniazid for the treatment of latent tuberculosis infection in individuals ages 2 years and older at high risk of progression to tuberculosis disease. Source: FDA website
New Indication 12-04-14
Highly Concentrated Potassium Chloride
Baxter International announced a voluntary recall of one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL due to a complaint of mislabeling of the overpouch. Contact your healthcare professional with any questions. Details including affected lot number may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424276.htm. Source: FDA website
Drug Recall 11-21-14
Tecfidera
The Food and Drug Administration (FDA) announced that a patient with multiple sclerosis (MS) who was being treated with Tecfidera developed a rare brain infection called progressive multifocal leukoencephalopathy (PML) and later died. The patient was not taking any other drugs associated with PML. The prescribing information will be updated to reflect this case report. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424752.htm
Drug Warning 11-25-14
Xgeva
The Food and Drug Administration (FDA) approved XgevaTM (denosumab injection) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Source: FDA website.
New Indication 12-08-14
Naftin
The Food and Drug Administration (FDA) approved Naftin® (naftifine 2% cream and gel) for the treatment of interdigital type tinea pedis in individuals aged 12-17 years. Source: FDA website.
New Indication 12-08-14
Cyramza
The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) for the treatment of individuals with metastatic non-small cell lung cancer (NSCLC).
New Indication 12-12-14
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) for the treatment of gastroenteropancreatic neuroendocrine tumors in adults with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival. Source: FDA website
New Indication 12-29-14
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets) for use in individuals with cystic fibrosis (CF) ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 12-29-14
Natroba
The Food and Drug Administration (FDA) approved an expanded age range for NatrobaTM (spinosad topical suspension) to include children 6 months and older who have head lice. Source: FDA website
New Indication 01-06-15
Dyloject
The Food and Drug Administration (FDA) approved DylojectTM (diclofenac sodium injection) for the management of mild to moderate pain in adults, and for moderate to severe pain alone or in combination with opioid analgesics. Source: FDA website
New Drug 12-30-14
Signifor LAR
The Food and Drug Administration (FDA) approved Signifor® LAR (pasireotide diaspartate long-acting release injection) for the treatment of individuals with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Source: FDA website
New Drug 12-16-14
Soolantra
The Food and Drug Administration (FDA) approved Soolantra® (ivermectin topical cream) for the treatment of inflammatory lesions of rosacea. Source: FDA website
New Drug 12-23-14
Saxenda
The Food and Drug Administration (FDA) approved Saxenda® (liraglutide injection) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30kg/m2 (obese) or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Source: FDA website
New Drug 12-23-14
Namzaric
The Food and Drug Administration (FDA) approved NamzaricTM (memantine extended-release/donepezil capsules) for the treatment of moderate to severe Alzheimer's dementia in individuals stabilized on memantine and donepezil. Source: FDA website
New Drug 12-29-14
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (9-valent human papillomavirus types, recombinant vaccine injection) for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV) in females 9-26 years old and males 9-15 years old. Source: FDA website
New Drug 12-10-14
Fluzone Intradermal Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® Intradermal Quadrivalent (seasonal influenza virus quadrivalent vaccine injection) for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses for adults aged 18-64. Source: FDA website
New Drug 12-12-14
QNASL
The Food and Drug Administration (FDA) approved QNASLTM (beclomethasone dipropionate nasal spray) for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years old. This is a non-aqueous hydrofluoroalkane (HFA) nasal product. Source: FDA website
New Drug 12-19-14
Xtoro
The Food and Drug Administration (FDA) approved Xtoro® (finafloxacin otic suspension) for the treatment of acute otitis externa (swimmer's ear). Source: FDA website
New Drug 12-17-14
Lynparza
The Food and Drug Administration (FDA) approved LynparzaTM (olaparib capsules) for the treatment of advanced ovarian cancer. Source: FDA website
New Drug 12-19-14
Zerbaxa
The Food and Drug Administration (FDA) approved ZerbaxaTM (ceftolozane/tazobactam injection) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria. Source: FDA website
New Drug 12-19-14
Rapivab
The Food and Drug Administration (FDA) approved RapivabTM (peramivir injection) for the treatment of acute uncomplicated influenza in adults who have been symptomatic for no more than two days. Source: FDA website
New Drug 12-19-14
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with unresectable or metastatic melanoma. Source: FDA website
New Drug 12-22-14
Viekira Pak
The Food and Drug Administration (FDA) approved Viekira PakTM (ombitasvir/paritaprevir/ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Source: FDA website
New Drug 12-19-14
Ziprasidone
The Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to other parts of the body. The drug labeling will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm426624.htm Source: FDA website
Drug Warning 12-11-14
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for use in previously treated individuals with Waldenstrom's macroglobulinemia. Source: FDA website
New Indication 01-29-15
Rytary
The Food and Drug Administration (FDA) approved Rytary™ (carbidopa/levodopa extended-release capsules) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Source: FDA website
New Drug 01-08-15
Duopa
The Food and Drug Administration (FDA) approved Duopa® (carbidopa/levodopa enteral suspension) for the treatment of motor fluctuations for people with advanced Parkinson's disease. Source: FDA website
New Drug 01-12-15
Prestalia
The Food and Drug Administration (FDA) approved Prestalia® (amlodipine/perindopril tablets) for the treatment of hypertension. Source: FDA website
New Drug 01-21-15
Bexsero
The Food and Drug Administration (FDA) approved Bexsero® (meningococcal group B vaccine injection) for active immunization to prevent invasive meningitis B in individuals aged 10-25 years. Source: FDA website
New Drug 01-26-15
Natpara
The Food and Drug Administration (FDA) approved Natpara® (parathyroid hormone injection) as adjunct to calcium and vitamin D to control hypocalcemia in individuals with hypoparathyroidism. Source: FDA website
New Drug 01-26-15
Triferic
The Food and Drug Administration (FDA) approved Triferic™ (soluble ferric pyrophosphate solution) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease (CKD). Triferic is introduced into bicarbonate concentrate at the dialysis clinic and then mixed into the dialysate. Source: FDA website
New Drug 01-26-15
Prezcobix
The Food and Drug Administration (FDA) approved Prezcobix™ (darunavir/cobicistat tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in combination with other antiretroviral agents for treatment-naïve and treatment experienced adults with no darunavir resistance-associated substitutions. Source: FDA website
New Drug 01-30-15
Evotaz
The Food and Drug Administration (FDA) approved Evotaz™ (atazanavir/cobicistat tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults. Source: FDA website
New Drug 01-30-15
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx™ (secukinumab injection) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 01-21-15
Savaysa
The Food and Drug Administration (FDA) approved Savaysa™ (edoxaban tablets) for the reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation (NVAF), treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of therapy with an injectable anticoagulant. Source: FDA website
New Drug 01-08-15
Prescription and over-the-counter pain medicines
The Food and Drug Administration (FDA) has responded to concerns regarding the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. They have evaluated the data and determined it is too limited to make any recommendations at this time. The FDA states that the use of pain medicines during pregnancy should be carefully considered. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm429604.htm Source: FDA website
Drug Warning 01-09-15
Vyvanse
The Food and Drug Administration (FDA) approved Vyvanse® (lisdexamfetamine dimesylate capsules) for the treatment of binge-eating disorder in adults. Source: FDA website
New Indication 02-02-15
Glyxambi
The Food and Drug Administration (FDA) approved Glyxambi® (empagliflozin/linagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments. Source: FDA website
New Drug 01-30-15
Zohydro ER
The Food and Drug Administration (FDA) approved Zohydro® ER (hydrocodone bitartrate extended-release capsules) with abuse deterrent properties for the management of pain. Source: FDA website
New Drug 01-30-15
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for the treatment of estrogen receptor positive, human epidermal growth factor receptor (HER) 2 negative breast cancer in combination with letrozole. Source: FDA website
New Drug 02-03-15
Pazeo
The Food and Drug Administration (FDA) approved Pazeo™ (olopatadine hydrochloride ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
New Drug 02-02-15
Banzel
The Food and Drug Administration (FDA) approved Banzel® (rufinamide tablets) as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric individuals aged 1-4 years old. Source: FDA website
New Indication 02-13-15
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) for expanded use in newly diagnosed multiple myeloma in combination with dexamethasone. Source: FDA website
New Indication 02-18-15
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab ophthalmic injection) for the treatment of diabetic retinopathy in individuals with diabetic macular edema (DME). Source: FDA website
New Indication 02-18-15
Dutrebis
The Food and Drug Administration (FDA) approved Dutrebis™ (lamivudine/raltegravir tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Source: FDA website
New Drug 02-06-15
Lenvima
The Food and Drug Administration (FDA) approved Lenvima™ (lenvatinib capsules) for the treatment of individuals with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine (RAI) therapy. Source: FDA website
New Drug 02-13-15
Lenvima
The Food and Drug Administration (FDA) approved Lenvima™ (lenvatinib capsules) for the treatment of individuals with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine (RAI) therapy. Source: FDA website
New Drug 02-13-15
Dymista
The Food and Drug Administration (FDA) approved Dymista™ (azelastine/fluticasone propionate nasal spray) for the relief of symptoms of seasonal allergic rhinitis (SAR) in individuals ages 6-11 who require treatment with both components. Source: FDA website
New Indication 02-20-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for individuals with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Source: FDA website
New Indication 02-04-15
Toujeo
The Food and Drug Administration (FDA) approved Toujeo® (insulin glargine injection) for the treatment of type 1 and type 2 diabetes. Source: FDA website
New Drug 02-25-15
Elepsia XR
The Food and Drug Administration (FDA) approved Elepsia XR™ (levetiracetam extended-release tablets) for adjunctive therapy in the treatment of partial onset seizures in individuals 12 years of age and older with epilepsy. Source: FDA website
New Drug 02-25-15
Liletta
The Food and Drug Administration (FDA) approved Liletta™ (levonorgestrel-releasing intrauterine system) approved for the prevention of pregnancy for up to 3 years. Source: FDA website
New Drug 02-27-15
Avycaz
The Food and Drug Administration (FDA) approved Avycaz™ (ceftazidime/avibactam injection) for complicated intra-abdominal infections in combination with metronidazole. It is also approved for complicated urinary tract infections. Source: FDA website
New Drug 02-25-15
Zarxio
The Food and Drug Administration (FDA) approved Zarxio® (filgrastim injection) for neutropenia in individuals with cancer receiving myelosuppressive chemotherapy, in individuals with acute myeloid leukemia receiving induction or consolidation chemotherapy, in individuals with cancer undergoing bone marrow transplantation, in individuals undergoing autologous peripheral blood progenitor cell collection and therapy, and in individuals with severe chronic neutropenia. Zarxio is the first biosimilar product approved in the United States. Source: FDA website
New Drug 03-06-15
Farydak
The Food and Drug Administration (FDA) approved Farydak® (panobinostat capsules) for the treatment of individuals with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulator. Farydak is used in combination with bortezomib and dexamethasone. Source: FDA website
New Drug 02-23-15
Cresemba
The Food and Drug Administration (FDA) approved Cresemba® (isavuconazonium sulfate capsules and injection) for adults with invasive aspergillosis and mucormycosis. Source: FDA website
New Drug 03-06-15
Testosterone products
The Food and Drug Administration (FDA) is requiring manufacturers of all approved prescription testosterone products to update their labeling regarding possible increased risk of heart attack and stroke with these products. In addition, labeling should clarify approved uses of these medications with cautions about using for low testosterone due to aging. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436280.htm Source: FDA website
Drug Warning 03-03-15
Saphris
The Food and Drug Administration (FDA) approved Saphris®(asenapine sublingual tablets) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric individuals aged 10-17 years. Source: FDA website
New Indication 03-13-15
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in children ages 2-5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene). Source: FDA website
New Indication 03-18-15
Unituxin
The Food and Drug Administration (FDA) approved Unituxin™ (dinutuximab injection) for pediatric individuals with high-risk neuroblastoma for use as part of a multimodal regimen including surgery, chemotherapy and radiation therapy for individuals who achieved at least a partial response to prior first-line multiagent, multimodality therapy. Source: FDA website
New Drug 03-10-15
Cholbam
The Food and Drug Administration (FDA) approved Cholbam® (cholic acid capsules) for the treatment of bile acid synthesis disorders and peroxisomal disorders. Source: FDA website
New Drug 03-17-15
Chantix
The Food and Drug Administration (FDA) issued a warning that the smoking cessation drug Chantix® (varenicline tablets) can change the way people react to alcohol with some experiencing increased intoxicating effects. The label will be updated to include this potential alcohol interaction. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437415.htm Source: FDA website
Drug Warning 03-09-15
Over-the-counter asthma products
The Food and Drug Administration (FDA) is warning consumers not to rely on over-the-counter (OTC) asthma products labeled as homeopathic. These products have not been evaluated by the FDA and may pose potential health risks. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439014.htm Source: FDA website
Drug Warning 03-19-15
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of diabetic retinopathy in individuals with diabetic macular edema (DME). Source: FDA website
New Indication 03-25-15
Qudexy XR
The Food and Drug Administration (FDA) approved Qudexy™ XR (topiramate extended-release capsules) as initial monotherapy in individuals 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Source: FDA website
New Indication 04-02-15
Quadracel
The Food and Drug Administration (FDA) approved Quadracel® (DTaP-poliovirus vaccine injection) for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis for children aged 4 to 6 years of age. Source: FDA website
New Drug 03-25-15
ProAir RespiClick
The Food and Drug Administration (FDA) approved ProAir® RespiClick (albuterol sulfate breath-actuated dry-powder oral inhalation) for the treatment of acute asthma symptoms. Source: FDA website
New Drug 04-01-15
Jadenu
The Food and Drug Administration (FDA) approved Jadenu™ (deferasirox tablets) for the treatment of chronic iron overload due to blood transfusions in individuals 2 years and older and for chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients greater than 10 years and older. Source: FDA website
New Drug 03-31-15
Mammograms
The Food and Drug Administration (FDA) is alerting individuals who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012 about possible problems with mammogram quality. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439723.htm Source: FDA website
Drug Warning 03-24-15
Zyprexa Relprevv
The Food and Drug Administration (FDA) has concluded a review of a study on schizophrenia drug Zyprexa® Relprevv™ (olanzapine pamoate injection) to determine the cause of elevated levels of the drug in two individuals who died. The results were inconclusive. The FDA is not recommending any changes to current prescribing at this time. Patients should not stop receiving treatment without first talking to their health care provider. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439472.htm Source: FDA website
Drug Warning 03-23-15
Prescription Center Pharmacy
The Food and Drug Administration (FDA) is joining the North Carolina Board of Pharmacy to urge health care professionals and consumers not to use products made and distributed by the Prescription Center Pharmacy in Fayetteville, North Carolina due to a lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm441001.htm Source: FDA website
Drug Warning 04-02-15
Neupogen
The Food and Drug Administration (FDA) approved Neupogen® (filgrastim injection) to increase survival in individuals acutely exposed to myelosuppressive doses of radiation (hemopoietic syndrome of acute radiation syndrome). Source: FDA website
New Indication 04-06-15