Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Mupirocin Calcium Cream USP, 2%. Glenmark will commence shipping immediately.
Mupirocin calcium cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S aureus and S pyogenes.
Based on IMS Health sales data for the 12 month period ending September 2012, Mupirocin Calcium Cream garnered sales of $ 56.5 million.
Glenmark’s current portfolio consists of 83 products authorised for distribution in the US and 46 ANDA’s pending approval with the 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.
EP News Bureau – Mumbai