US FDA gives tentative nod for Teva’s Risedronate Sodium Tablets

The US Food and Drug Administration has granted tentative approval for the Teva Pharmaceutical’s ANDA for 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 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.