US FDA has granted ANDA nod to Mumbai-based global pharma major Glenmark Pharmaceuticals for the manufacturing of Desonide Cream, used to treat variety of skin conditions.
The company in a BSE filing said: “Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Desonide Cream, 0.05 per cent, the generic version of Desonide Cream, 0.05 per cent of Perrigo New York Inc.
The medication has achieved an annual sales of approximately USD 44.6 million, according to IMS Health sales data for the 12 month period ending May 2017.
Currently, its portfolio consists of 120 products authorized for distribution in the US marketplace. Furthermore, 65 ANDA are pending for approval with the FDA.
Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, the company said.