Lupin Gets Tentative OK on Generic Zoloft
January 2, 2007
Indian generic drug maker Lupin Pharmaceuticals said Tuesday it has received a tentative OK of a generic version of Pfizer’s Zoloft.
The company said the U.S. Food and Drug Administration has given tentative approval to sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg dosage forms.
Lupin said it will get full FDA approval on the generic product in February upon expiration of the 180-day marketing exclusivity period granted to the first company to market a generic formulation of the top-selling anti-depressant.
The drug is indicated for the treatment of major depressive disorder.
Lupin estimated Zoloft annual sales at approximately $3.1 billion for the 12 months ending July 2006, quoting data from IMS Health.