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Teva Pharmaceutical Industries Ltd. announced today that the U.S. FDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Lilly’s osteoporosis treatment Evista
JERUSALEM, Israel | April 17, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Lilly’s osteoporosis treatment Evista(R) (Raloxifene Hydrochloride) Tablets, 60 mg.
The brand product had annual sales of approximately $691 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the Southern District of Indiana. A trial date has not been set.
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. |
