RHONE-POULENC RORER CALCIMAR PHASE IV FRACTURE STUDY COMPLETION "UNLIKELY"; SANDOZ MIACALCIN NASAL SPRAY CLEARS FDA COMMITTEE FOR OSTEOPOROSIS
Executive Summary
Rhone-Poulenc Rorer considers it "unlikely" that a Phase IV bone fracture study of its injectable synthetic salmon calcitonin Calcimar (NDA 17-769) in postmenopausal osteoporotic women will be completed, the company reported to FDA's Endocrinologic & Metabolic Drugs Advisory Committee Nov. 18.