Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Ointment USP, 0.05%, the generic version of Temovate Ointment, 0.05% of Fougera Pharmaceuticals Inc.
According to IMS Health sales data for the 12 month period ending January 2017, the Temovate Ointment, 0.05% market1 achieved annual sales of approximately USD 175.3 million.
Glenmark's current portfolio consists of 113 products authorized for distribution in the U.S. marketplace and approximately 64 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Shares of the company gained Rs 0.9, or 0.1%, to trade at Rs 881.25. The total volume of shares traded was 6,211 at the BSE (9.35 a.m., Tuesday).