Teva got Tentative approval for Raloxifene tablets

Teva Pharma announced today that the USFDA has granted tentative approval to the Company's ANDA to market its generic version of Lilly's osteoporosis treatment Evista(R) (Raloxifene Hydrochloride) Tablets, 60 mg.
Raloxifene ([6-hydroxy-2-(4-hydroxyphenyl)- benzothiophen-3-yl]- [4-[2-(1-piperidyl)ethoxy]phenyl] –methanone) is an oral selective estrogen receptor modulator (SERM) that has oestrogenic actions on bone and anti-oestrogenic actions on the uterus and breast. It is used in the prevention of osteoporosis in postmenopausal women. On September 14, 2007, the USFDA announced approval of Raloxifene for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer
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 and Barr are involved in patent litigation concerning this product with ELI LILLY in the Indiana Southern District Court on following Orange book listed patents
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