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Consumer OTC Drugs

OTC Rogaine marketing exclusivity challenged in petition to FDA from D.C. law firm.

This article was originally published in The Tan Sheet

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Executive Summary

OTC ROGAINE THREE-YEAR MARKET EXCLUSIVITY CONTESTED by Washington, D.C. law firm Hyman, Phelps & McNamara in a Jan. 18 petition submitted to FDA. Filed on behalf of an unnamed client "that intends to market minoxidil for the treatment of baldness," the petition maintains that the data presented by Pharmacia & Upjohn in support of its Rx-to-OTC switch application fails to include "any new and essential clinical investigation."

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