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In Brief: Generic OTC minoxidil

Executive Summary

Generic OTC minoxidil: Lemmon and Barre-National gain ANDA approvals for minoxidil 2% April 5, the same week Pharmacia & Upjohn launches its OTC version of Rogaine. FDA approved the generics following a decision not to grant Pharmacia & Upjohn the three-year marketing exclusivity it had requested for the OTC switch ("The Pink Sheet" Feb. 12, T&G-12). Bausch & Lomb, which along with Lemmon previously had gained tentative ANDA approvals for generic minoxidil, has not yet received final approval. The generics are approved only for OTC use in male pattern baldness. The generic firms must submit stability data on minoxidil packaged in the applicator used in female alopecia to gain approval for that indication...

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