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Committee Clear On Need For Fracture Data For New Calcitonin Drugs

 
• By Cathy Dombrowski

A March 5 FDA advisory panel gave a mixed assessment of whether nasal spray formulations of the products should remain on the market for postmenopausal osteoporosis, but overwhelmingly agreed that new versions should meet a higher efficacy standard.

An FDA advisory committee’s reconsideration of the benefits and risks of calcitonin drugs used to treat post-menopausal women with osteoporosis has clear implications for future products, but the agency received a mixed view on how to regulate products already approved.

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