Glenmark Generics, USA, the subsidiary of Glenmark Generics, has launched Hydrocortisone Butyrate cream USP, 0.1 per cent in the US. The company received approval from the US FDA for Abbreviated New Drug Application (ANDA) for its generic version of Locoid Lipocream on September 27, 2013.
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 indicated 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 three months to 18 years of age. According to IMS Health sales data for the 12 month period ending September 2013, Hydrocortisone Butyrate cream garnered annual sales of approximately $ 36.8 million.
Glenmark’s current portfolio consists of 90 products authorised for distribution in the US marketplace and 56 ANDA’s pending approval with the U.S. FDA.
EP News Bureau – Mumbai
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