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Thursday, April 1, 2010

Lupin : FDA tentative approval for Eszopiclone tablets

Lupin PharmaceuticalsMarch 20, 2010 - Pharma Major, Lupin Limited announced that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data... Lupin Pharmaceuticals' Press Release -