Glenmark Pharmaceuticals receives ANDA approval for Hydrocortisone Valerate Ointment USP, 0.2%
Deepthi | Myequity news | Date : 17-12-2018 10:10:00 IST
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort® Ointment, 0.2%, of Sun Pharmaceutical Industries, Inc. Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2%, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization. This is Glenmark’s first granted CGT product approved by the FDA.
According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort® Ointment, 0.2% market achieved annual sales of approximately $11.1 million.
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.