In Brief: Sandoz' Miacalcin
Executive Summary
Sandoz' Miacalcin: Salmon calcitonin nasal spray is "approvable" as of Feb. 10. FDA's Endocrinologic & Metabolic Drugs Advisory Committee recommended Miacalcin for approval Nov. 18 as a second-line therapy following failure of or intolerance to estrogen therapy for osteoporotic postmenopausal women. The recommendation was conditioned on a Sandoz commitment to complete a five-year Phase IV postmarketing study examining the effects of the drug on fracture rates...
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