Mumbai-based Glenmark Pharmaceutical Limited, which focuses on research to develop new chemical entities (NCEs) and new biological entities (NBEs), has received final approval from the US health regulator for its generic Fluocinonide cream.
This cream is used for treating a variety of skin infections. It has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream.
Glenmark Pharmaceuticals said, “According to IMS Health sales data for the 12-month period ending March 2014, Fluocinonide cream garnered annual sales of approximately $103 million."
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.
Its current portfolio consists of 93 products authorised for distribution in the US market and it has 71 ANDAs pending approval with the USFDA.
(Edited by Joby Puthuparampil Johnson)