Mar 3 2011
Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.
Glenmark's levocetirizine dihydrochloride tablets are currently available and shipping will commence immediately from the Company's New Jersey facility. Total U.S. sales as reported by IMS Health for the 12 month period ending December 2010 were approximately USD 231 million.
The Company's current portfolio consists of 69 generic products authorized for distribution in the U.S. market and approximately 40 ANDA's filed with the U.S. FDA pending approval. 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.
SOURCE Glenmark Pharmaceuticals Ltd.