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FDA approves Actonel dose for postmenopausal osteoporosis

Procter & Gamble said the FDA has approved a new dose for Actonel that will give patients the option of taking one Actonel 75mg tablet on two consecutive days, for a total of two tablets monthly, to treat and prevent their postmenopausal osteoporosis.

P&G said that Actonel (risedronate sodium tablets), a therapy proven to reduce the risk of both vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, will soon be available in this monthly two-day dose option.

P&G said that in previous clinical trials of daily Actonel 5 mg, nonvertebral fracture reduction was demonstrated at a composite endpoint of six sites commonly associated with osteoporotic fractures – leg, humerus, hip, wrist, collarbone, and pelvis.