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Lemmon, Barre ANDAs for topical minoxidil clear FDA; Rogaine exclusivity denied.

This article was originally published in The Tan Sheet

Executive Summary

OTC ROGAINE PRODUCTS DENIED THREE-YEAR WAXMAN/HATCH EXCLUSIVITY by FDA on April 5. As a result of the agency's ruling, Pharmacia & Upjohn's recently-switched minoxidil 2% hair regrowth treatment will enter the OTC market unprotected from competing private-label versions.

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