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Procter-Syntex to launch Femstat 3 OTC switch yeast infection cream in spring.

Executive Summary

PROCTER-SYNTEX FEMSTAT 3 OTC THREE-DAY YEAST INFECTION CREAM TO LAUNCH in early spring, following FDA's Dec. 21 approval of the Rx-to-OTC switch product. Femstat 3 (butoconazole nitrate 2%) will be the first three-day OTC vaginal yeast infection therapy available. It is the first OTC switch cleared by FDA without an advisory committee review since the Nonprescription Drugs Advisory Committee was formed in 1992. Procter-Syntex, a joint venture between Procter & Gamble and Roche/Syntex, filed the NDA for Femstat 3 on Dec. 17, 1993 and resubmitted it Aug. 31, 1995.
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