FDA APPROVES ACTONEL FOR MEN WITH OSTEOPOROSIS

The FDA has approved sanofi-aventis' Actonel (risedronate sodium tablets) 35 mg to increase bone mass in men with osteoporosis. The drug was previously approved for use in men and women to prevent and treat certain forms of steroid-induced osteoporosis. Actonel 35 mg is also approved for the prevention and treatment of osteoporosis in postmenopausal women.

The approval the new indication is based on a two-year, placebo-controlled, double-blind multicenter clinical trial of 284 male patients with osteoporosis. In the trial, patients treated with once-a-week Actonel 35 mg experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured.