Glenmark gets final nod from USFDA for skin infection cream
The firm's generic version of Medicis' Vanos cream, Fluocinonide, has been granted approval by USFDA
New Delhi: Glenmark Pharmaceuticals Ltd has received final approval from the US health regulator for its generic Fluocinonide cream used for treating a variety of skin infections.
Glenmark Generics Inc., the subsidiary of Glenmark Generics Ltd, has been granted final approval from the US 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 12-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’ 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 authorized for distribution in the US market and it has 71 ANDA’s pending approval with USFDA, it added.
Shares of Glenmark Pharmaceuticals on Tuesday ended at ₹ 546.75, up 1.41% from its previous close.
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