Glenmark Pharmaceuticals receives ANDA approval for Teriflunomide Tablets, 7 mg and 14 mg
Deepthi | Myequity news | Date : 16-11-2018 10:30:00 IST
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Teriflunomide Tablets, 7 mg and 14 mg, a generic version of Aubagio®1 Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC. With this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg.
According to IQVIATM sales data for the 12 month period ending September 2018, the Aubagio® Tablets, 7 mg and 14 mg market2 achieved annual sales of approximately $1.6 billion*.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.