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Glenmark Generics Receives Approval For Hydrocortisone Butyrate Cream USP, 0.1%

Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark Generics Inc. had received the approval from US FDA for Hydrocortisone Butyrate Cream USP, 0.1 percent, abbreviated new drug approval (ANDA), a generic version of Locoid Lipocream.

In April 2011, Glenmark had entered into a royalty-bearing license agreement with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV to settle a patent infringement suit against the commercialization of generic version of Locoid Lipocream and agreed to launch in near the end of CY2013. Glenmark is entitled to 180 days of exclusivity with respect to its Hydrocortisone Butyrate Cream, as it is the first generic company to file an ANDA for the product.

Hydrocortisone Butyrate Cream is indicted for the Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age.

According to ISM Health sales data, Hydrocortisone Butyrate Cream had sales of around $34 million for the 12 months ended June 30, 2013.

AT the BSE, Glenmark Pharmaceuticals shares are currently trading at Rs.530.95, up 1.55 percent from the previous close.

by RTT Staff Writer

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