Glenmark Generics, USA, the subsidiary of Glenmark Generics Ltd, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (FDA) for imiquimod cream 5 per cent, their generic version of Aldara by Medicis Pharmaceutical Corporation and has commenced shipping immediately upon approval.
Imiquimod cream 5 per cent is indicated for the topical treatment of clinical typical, non-hyperkeratotic, non-hypertrophic actinic keratoses on the face of scalp in immunocompetent adults and for the treatment of external genital and perianl warts/condyloma acuminate in patients 12 year old or older.
According to IMS Health sales data for the 12 month period ending December 2011, imiquimod cream garnered annual sales of approximately US$ 244 million.
Glenmarks' current profile consists of 77 products authorised for distribution in US market place and 40 ANDAs pending approval with US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.