FDA drug approvals - October 2014


FDA actions in brief, fast-track designations, priority review.

FDA actions in brief

Dapagliflozin and metformin hydrochloride extended-release (Xigduo XR, AstraZeneca) once-daily tablet was approved for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Trumenba (Wyeth Pharmaceuticals, a subsidiary of Pfizer), the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age, was approved.

FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharmaceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter. 

FDA has approved Antihemophilic Factor (Recombinant), Porcine Sequence] (Obizur, Baxter) for the treatment of bleeding episodes in adults with acquired hemophilia A.

New labeling for morphine sulfate and naltrexone hydrocholoride (Embeda, Pfizer) extended-release capsules was approved describing the product's abuse-deterrent properties consistent with FDA's 2013 draft guidance. Embeda is an opioid anlgesic to treat pain severe enough to require daily, around-the-clock and for which alternative treatment options are inadequate.The new labeling includes a claim indicating that the drug has properties that are expected to reduce oral abuse when the product is crushed.

Pirfenidone (Esbiret, InterMune) was approved for the treatment of idiopathic pulmonary fibrosis.

Nintendanib (Ofev, Boehringer Ingelheim) was approved for the treatment of idiopathic pulmonary fibrosis.

Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.

Netupitant and palonosetron (Akynzeo, Eisai) was approved to treat nausea and vomiting in patients undergoing cancer chemotherapy.

Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm. 

Sulfur hexafluoride lipid microsphere (



Bracco Diagnostics

) ultrasound imaging agent was approved for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.

Brincidofovir (Chimerix) antiviral drug was approved to be administered to treat Ebola.

Aflibercept (Eylea, Regeneron Pharmaceuticals) injection solution was approved to treat visual impairment caused by diabetic macular edema (DME).

Xarelto (rivaroxaban) Starter Pack (Janssen) for deep vein thrombosis (DVT) and/or pulmonary embolism (PE) treatment was approved to help simplify the dosing for the initial 30-day treatment period when patients are at greatest risk of having another DVT or PE. Rivaroxaban was the first Factor Xa inhibitor approved for DVT/PE treatment and reducing the risk of their recurrence in November 2012.

The extension of adalimumbab (Humira, AbbVie) indication has been approved for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to lowering signs and symptoms in patients aged 2 years and older.

Complete response

Carbamazepine (Carbella, Lundbeck) injection, an investigational intravenous formulation of the anti-epileptic drug carbamazepine. The complete response letter requested additional Chemistry, Manufacturing and Controls data.

Recommended for approval

AIN457 (secukinumab, Novartis) for patients with moderate-to-severe plaque psoriasis

Fast-track designations

ARA290 (Araim Pharmaceuticals) for treatment of sarcoidosis-associated small fiber neuropathy.

TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) (Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd.), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC),

NKTT120 (NKT Therapeutics) a humanized monoclonal antibody that specifically depletes iNKT cells, a regulatory T cell that has been demonstrated to be a key mediator of organ damage in preclinical models of sickle cell disease.

NurOwn (BrainStorm Cell Therapeutics), an adult stem cell treatment, for amyotrophic lateral sclerosis (ALS).

Priority review

Ranibizumab injection (Lucentis, Genentech) for the treatment of diabetic retinopathy.

Investigational bispecific T cell engager (BiTE, Amgen) antibody construct, blinatumomab for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow

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