The USFDA has recently granted tentative approval to Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg, the generic version of Pfizer (NYSE:PFE)’s ZOLOFT®.
ZOLOFT® tablets are indicated for the treatment of majaor depressive disorders, whose annual sales of of approximately $3.1 billion for the twelve months ended July 2006, based on IMS sales data.
Final approval of Lupin’s generic version is expected upon the expiration of the first ANDA filer's 180-day marketing exclusivity in February 2007. After which, Lupin's Sertraline Tablets will officially become the AB-rated generic equivalent of Pfizer's ZOLOFT® Tablets.
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited (BOM:500257), one of India’s top five Pharmaceutical companies.
Source: PR Newswire
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