Glenmark Gets Final Nod From US Drug Regulator for Skin Cream

Glenmark Gets Final Nod From US Drug Regulator for Skin Cream
New Delhi:

Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its generic Fluocinonide cream used for treating a variety of skin infections.

Glenmark Generics Inc USA, subsidiary of Glenmark Generics Ltd, has been granted final approval from the US health regulator for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1 per cent), 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.

As of 2:43 p.m., shares in Glenmark were trading at Rs 546.25 apiece on the BSE, up 1.32 per cent from the previous close.