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OTC Rogaine three-year market exclusivity objected to by DC law firm petition.

This article was originally published in The Rose Sheet

Executive Summary

OTC ROGAINE THREE-YEAR MARKET EXCLUSIVITY SHOULD BE DENIED, Washington, DC law firm Hyman, Phelps & McNamara stated in a Jan. 18 petition submitted to FDA. Filed on behalf of "a 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," a requirement for the three-year exclusivity award.
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