Glenmark Generics receives final ANDA approval for Eszopiclone Tablets

16 Apr 2014 Evaluate

Glenmark Generics Inc., 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 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. Lunesta garnered annual sales of $824 million according to IMS Health, for the 12 month period ending December 2013.

Glenmark’s current portfolio consists of 91 products authorized for distribution in the US marketplace and 63 ANDA’s pending approval with the USFDA. 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.

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