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Rogaine Extra Strength use by women not a health risk, FDA advisory committee says.

This article was originally published in The Rose Sheet

Executive Summary

ROGAINE EXTRA STRENGTH FOR MEN WILL ATTRACT FEMALE BUYERS, FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committees predicted, in spite of proposed labeling statements informing customers that the 5% minoxidil antibaldness treatment is "not for use by women." At a July 16 joint meeting in Bethesda, Md., 16 NDAC committee members agreed that a "substantial number of women" would purchase Pharmacia & Upjohn's Rogaine Extra Strength, which awaits OTC approval, even though it will clearly be labeled for use by men only. Two of the panelists disagreed with the majority. Committee members voted 13-4 to support OTC use of Rogaine 5% for men ("The Rose Sheet" July 21, p. 5).



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