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Rogaine Extra Strength for Men data support more hair regrowth than original formula.

This article was originally published in The Tan Sheet

Executive Summary

ROGAINE EXTRA STRENGTH "FASTER" HAIR REGROWTH CLAIM NEEDS FURTHER DATA before it can be included in proposed labeling for the baldness treatment, FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committees recommended at a July 16 joint meeting in Bethesda, Md. The group agreed that, because onset of action for the 5% minoxidil solution was not a primary endpoint of sponsor Pharmacia & Upjohn's studies, the claims "Provides more hair regrowth" and "Provides regrowth sooner" are unsubstantiated and should not appear in labeling.

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