Glenmark Pharmaceuticals gets USFDA tentative nod for Calcipotriene and Betamethasone Dipropionate Foam

9 May 2022 , 10:14 AM

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar Foam, 0.005%|0.064%, of Leo Pharma AS.

According to IQVIATM sales data for the 12 month period ending March 2022, the Enstilar Foam, 0.005%|0.064% market achieved annual sales of approximately $115.2 million.

Glenmark’s current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 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.

At domestic front, on the BSE Glenmark Pharmaceuticals was trading at Rs408 apiece down by Rs2.75 or 0.67%, at around 10:16 AM.