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.
