Glenmark Pharma gets USFDA nod for skin treatment ointment

Glenmark Pharmaceuticals on Friday said it has received final approval from the US health regulator for Pimecrolimus Cream, used to treat skin conditions such as eczema. The approved product is a generic version of Elidel Cream, 1 percent, of Bausch Health US, LLC.

Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Pimecrolimus Cream, 1 percent, the company said in a BSE filing. Citing IQVIA sales data, Glenmark said, Elidel Cream achieved annual sales of approximately USD 198.8 million in the 12-month period ended July 2019.

The company said its current portfolio consists of 160 products authorized for distribution in the US and 55 Abbreviated New Drug Application's (ANDA) pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.22 percent higher at Rs 384.35 apiece on BSE.