USFDA

Roche announced that the US Food and Drug Administration (FDA) has approved Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes, which can invade normal tissues and organs in the body.

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Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.

Antares Pharma, Inc. announced that, the Company received a letter from the U.S. Food and Drug Administration (FDA) stating that, as part of their ongoing review of the Company’s New Drug Application (NDA) for XYOSTED™ (testosterone enanthate) injection, they have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.

The U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for Mylan´s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

The U.S. Food and Drug Administration approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.

Zydus Cadila has received the final approval from the USFDA to market Dutasteride Capsules, 0.5 mg and Amitriptyline Hydrochloride Tablets USP in strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg.

Janssen Research & Development, LLC (Janssen) announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease. The application also applies to INVOKANA®’s fixed-dose combinations, INVOKAMET® and INVOKAMET® XR, and is based on findings from the landmark CANVAS clinical trial program, which were presented at a special symposium at the American Diabetes Association 77th Scientific Sessions in June 2017 and simultaneously published in The New England Journal of Medicine.

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

BioCryst Pharmaceuticals, Inc a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg, the generic version of Nitrostat® Sublingual Tablets, 0.3 mg, 0.4 mg, and 0.6 mg, of Pfizer, Inc.