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FDA Endocrinologic & Metabolic Drugs Advisory Committee

Executive Summary

On July 24, the committee will discuss the osteoporosis indication of Rhone-Poulenc Rorer's Calcimar (injectable salmon calcitonin) "in light of recently acquired efficacy data." In March, the committee declined to recommend approval for Norwich Eaton's Didronel PMO (etidronate) for osteoporosis after a follow- up study showed a 50% increase in new vertebral fractures during the third year of treatment ("The Pink Sheet" March 11, p. 3). On July 25, the committee will discuss safety and efficacy of Miles' Glucobay (acarbose), an alpha-glucosidase inhibitor for diabetes. The meetings will start at 9 a.m. both days at the Holiday Inn Crowne Plaza, Regency Room, 1750 Rockville Pike, Rockville, MD.
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PS019347

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