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In Brief: Pharmacia & Upjohn OTC Rogaine Extra Strength

Executive Summary

Pharmacia & Upjohn OTC Rogaine Extra Strength: FDA's Nonprescription and Dermatologic & Ophthalmic Drugs Advisory Committees recommend OTC approval of 5% strength minoxidil solution for men July 16. P&U initially submitted an NDA in December 1995 as an Rx product, which was deemed "approvable" a year later. In February P&U proposed that the 5% product go OTC directly. Committees determine P&U claim that Rogaine 5% produces "more hair growth" than the currently marketed 2% product is supported, but P&U claim that the 5% solution leads to "faster" hair growth needs further data. P&U is pursuing approval of Rogaine Extra Strength for women separately...
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