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www.fdanews.com/articles/75349-teva-announces-tentative-approval-of-risedronate-tablets

TEVA ANNOUNCES TENTATIVE APPROVAL OF RISEDRONATE TABLETS

August 12, 2005

Teva Pharmaceutical has announced that the FDA has granted tentative approval for its Risedronate Sodium Tablets, 5 mg, 30 mg and 35 mg. Final approval is expected upon the resolution of pending patent litigation.

Teva's Risedronate Sodium Tablets are the AB-rated generic equivalent of Procter & Gamble's Actonel tablets, a product indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget's disease.