FDA drug approvals-January 2015

January 7, 2015

FDA actions in brief, recommendations for approval, fast-track designations.

FDA actions in briefs

Ibrutinib (Imbruvica, Pharmacyclics and Janssen) was granted expanded approval for previously treated patients with Waldenstrom's macroglobulinemia, a rare form of cancer that begins in the body's immune system. The drug received breakthrough therapy designation for this use.

Darunavir 800 mg/cobicistate 150 mg (PrezcobixJanssen) once-daily fixed dose was approved for the treatment of human antiretroviral agents for treatment-naive and treatment experienced adults with no darunavir resistance-associated substitutions.

Parathyroid horomone (Natpara, NPS Pharmaceuticals) was approved to control hypocalcemia in patients with hypoparathyroidism.

Ferric pyrophosphate citrate (Triferic, Rockwell Medical Inc.) was approved for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease

Secukinumab (Cosentyx, Novartis) was approved for the treatment of moderate-to-severe plaque psoriasis.

The first set of mobile medical apps that will allow diabetic patients to share data with others from a continuous glucose monitor (CGM) (Dexcom Inc.) was granted permission for marketing.

Phenylephrine hydrochloride ophthalmic solution (2.5% and 10%) (Akorn) was approved to dilate the pupil before ocular examinations.

Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) (Baxter International) for treatment of primarily acute kidney injury patients

Long-acting release (LAR) pasireotide (Signifor, Novartis) for injectable suspension was approved for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Carbidopa and levodopa (DuopaAbbVie) enteral suspension was approved for the treatment of motor fluctuations for people with advanced Parkinson's disease. Duopa is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube.

Edoxaban tablets (SavaysaDaiichi Sankyo Co.) was approved to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Extended-release oral capsule formulation of carbidopa-levodopa (RytaryImpax Pharmaceuticals, a division of Impax Laboratories, Inc.) was approved for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. Rytary is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors.

Gadobutrol (GadavistBayer) injection was approved as the first magnetic resonance contrast agent for pediatric patients younger than than 2 years of age.

Recommended for approval

Isavuconazonium (Cresemba, Astellas) once-daily intravenous and oral braod-spectrum for the treatment of invasive aspergillosis, invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.

Ivestigational biosimilar filgrastim (Sandoz, a Novartis company) for use in all indications included in the reference product's (Amgen's Neupogen) label including prevention of infections in breast cancer patients undergoing chemotherapy, which reduces white blood cells, giving rise to a condition called neutropenia.

Priority review

Alirocumab (Praluent, Regeneron Pharmaceuticals, Inc. andSanofi) for treatment of patients with hypercholesterolemia.

Paliperidone palmitate (Janssen), a 3-month atypical antipsychotic for the treatment of schizophrenia in adults.

Sumatriptan / naproxen sodium (Treximet, Pernix Therapeutics) for use in adolescent patients, aged 12 to 17 years, for the acute treatment of migraine with or without aura.

Fast-track designations

BCX4161 (BioCryst) for the treatment of hereditary angiodema.

Cytarabine: daunorubicin (CPX-351, Celator Pharmaceuticals) for the treatment of elderly p[atients with secondary acute myeloid leukemia.

Sacituzumab Govitecan (IMMU-132) (Immunomedics) for triple-negative breast cancer that has failed prior therapies for metastatic disease.

Cenicriviroc (CVC) (Tobira Therapeutics, Inc.) for the treatment of nonalcoholic steatohepatitis, or NASH, in patients with liver fibrosis.

SHP609 (idursulfase-IT, Shire) for the treatment of neurocognitive decline associated with Hunter Syndrome.

Deflazacort (Marathon Pharmaceuticals) for treatment of patients with Duchenne Muscular Dystrophy (DMD). DMD, a fatal disorder that causes the progressive deterioration of muscle fibers, is the most common and severe form of muscular dystrophy among children/

Orphan drug designation

Tarextumab (anti-Notch 2/3, OMP-59R5) (OncoMed Pharmaceuticals) for the treatment of both pancreatic cancer and small cell lung cancer.

 

First-time generic approval

Esomeprazole magnesium delayed-release capsules (equiv to Nexium) in 20-mg and 40-mg capsules

Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA


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