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Glenmark Generics receives USFDA approval for Imiquimod Cream

07 Mar 2012 Evaluate

Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Imiquimod Cream 5%, their generic version of Aldara by Medicis Pharmaceutical Corporation and has commenced shipping immediately upon approval.

Imiquimod Cream 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults and for the treatment of external genital and perianal warts/condyloma acuminate in patients 12 years old or older. According to IMS Health sales data for the 12 month period ending December 2011, Imiquimod Cream garnered annual sales of approximately $244 million.

Glenmark's current portfolio consists of 77 products authorized for distribution in the US marketplace and 40 ANDA's pending approval with the USFDA.

Glenmark Pharma. Share Price

2270.45 60.60 (2.74%)
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