Shares of Glenmark Pharma surged 3.3 percent intraday Tuesday on getting USFDA approval for skin drug by its US subsidiary. “Glenmark Generics Inc, USA, the subsidiary of Glenmark Generics, has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1 percent, the generic version of Vanos Cream by Medicis,” says the company in its filing.
Fluocinonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. “VANOS Cream is a prescription corticosteroid (steroid hormone) used on the skin (topical) to treat adults and children 12 years of age and older with certain skin conditions that cause red, flaky, and itchy skin,” says Medicis.
According to IMS Health sales data for the 12 month period ending March 2014, Fluocinonide Cream garnered annual sales of approximately USD 103 million.
Glenmark’s current portfolio consists of 93 products authorised for distribution in the US marketplace and 71 ANDA’s pending approval with the US FDA. “In addition to these internal filings, Glenmark Generics Inc continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio,” it adds.