P&U Rogaine Extra Strength for Men faster hair growth claim not supported -- FDA advisors.
This article was originally published in The Rose Sheet
Executive Summary
P&U ROGAINE EXTRA STRENGTH FASTER ONSET CLAIM NEEDS MORE DATA before it could be included in the labeling for the anti-baldness 5% minoxidil solution treatment for men, FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committees concluded at a July 16 joint meeting in Bethesda, Md. The group agreed that because onset of action was not a primary endpoint investigated in Pharmacia & Upjohn's studies, the claims "grows more hair faster" and "hair growth experienced sooner" are unsubstantiated and should not appear on labeling.
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