Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug
Administration has granted final approval for the Company's Abbreviated New Drug
Application for Fluoxetine Capsules USP, 10 mg and 20 mg.
Shipment of
the product will begin immediately. Teva has been awarded a 180-day period of
marketing exclusivity.
Teva's Fluoxetine Capsules are the AB-rated
generic equivalent of Eli Lilly's Sarafem Pulvules, and are indicated for the
treatment of premenstrual dysphoric disorder.
According to IMS sales
data, the brand product had annual sales of about $39 million in the United
States for the twelve months that ended March 31, 2008.