US FDA approves Teva's generic for osteoporosis
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BY OUR PHARMA CORRESPONDENT
17th August,2005: A generic equivalent of the osteoporosis treatment risedronate sodium (Actonel) tablets manufactured by Teva Pharmaceuticals have been granted tentative approval by the US Food and Drug Administration.
The US FDA that has issued tentative approval for the company’s ANDA for risedronate sodium tablets in 5 mg, 30 mg and 35 mg strengths. Final approval is expected upon the resolution of pending patent litigation, Teva Pharmaceutical Industries Ltd announced in a press statement.
Teva’s risedronate sodium tablets are the AB-rated generic equivalent of Procter and Gamble’s Actonel tablets, a product indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget’s disease.
The brand product has annual sales of approximately $942 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva’s sales are in North America and Europe.
BY OUR PHARMA CORRESPONDENT
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