USFDA

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.

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy.

Pharma Major Lupin announced that it has received final approval for its Metronidazole Tablets USP, 250 mg and 500 mg from the United States Food and Drug Administration (FDA) to market a generic version of G.D. Searle LLC's Flagyl® Tablets, 250 mg and 500 mg.

Dr. Reddy’s Laboratories Ltd. has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL) and Metaxalone Tablets which are approved by the U.S. Food & Drug Administration (USFDA).