Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1%), Glenmark Pharmaceuticals said in a statement.
"According to IMS Health sales data for the twelve-month period ending March 2014, Fluocinonide cream garnered annual sales of approximately $103 million," it added.
The company's product is the generic version of Medicis's Vanos cream.
"Fluocinonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses," Glenmark said.
The company's current portfolio consists of 93 products authorised for distribution in the US market and it has 71 ANDA's pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 546.35 per scrip in the morning trade on BSE, up 1.34% from its previous close.