Teva announces tentative approval of alendronate sodium tablets
The US Food and Drug Administration has granted tentative approval for Teva Pharmaceutical Industries’s ANDA for Alendronate Sodium Tablets, 5 milograms (mg), 10 mg, 35 mg, 40 mg and 70 mg.
Alendronate Sodium Tablets are the generic equivalent of Merck's Fosamax Tablets. The product is indicated for the treatment and prevention of osteoporosis in postmenopausal women and the treatment of Paget's disease. The brand product has annual sales of approximately $1.5 billion.
Teva Pharmaceutical Industries, headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80 percent of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. — (menareport.com)
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