Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Alendronate Sodium Tablets, 5 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.

As previously announced, on November 4, 2002, the Delaware District Court found that Teva's ANDA filing for alendronate sodium infringes claim 1 of the '077 patent and that the patent term extension for the '077 patent is valid. Teva believes the decision is erroneous and has appealed the decision to the Court of Appeals for the Federal Circuit.