16 April 2014 | News | By BioSpectrum Bureau
Glenmark Generics receives final ANDA approval for Eszopiclone Tablets
US FDAfor Eszopiclone Tablets
Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Eszopiclone Tablets. Glenmark will commence distribution of the product immediately.
Eszopiclone Tablets are Glenmark's generic version of Sunovion's Lunesta®. Eszopiclone is indicated for the treatment of insomnia. The approval is for the 1mg, 2mg and 3mg tablets. For the 12 month period ending December 2013, Lunesta® garnered annual sales of USD 824 million according to IMS Health.
Glenmark's current portfolio consists of 91 products authorized for distribution in the U.S. marketplace and 63 ANDA's pending approval with the U.S. 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.