May 21, 2008 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Shipment of the product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, 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(R) Pulvules(R), and are indicated for the treatment of premenstrual dysphoric disorder (PMDD).
The brand product had annual sales of approximately $39 million in the United States for the twelve months that ended March 31, 2008, based on IMS sales data.
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