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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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.
JERUSALEM, Israel | May 20, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd. |
