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OTC Rogaine denied Waxman/Hatch exclusivity by federal court.

This article was originally published in The Tan Sheet

Executive Summary

ROGAINE EXCLUSIVITY: FDA "MERELY DESCRIBED" Rx-TO-OTC SWITCH NDA data requirements in a 1992 meeting with Upjohn representatives, according to Judge Robert Holmes Bell's April 30 decision to deny the company's motion for preliminary injunction to prevent generic manufacturers from selling private-label minoxidil 2% topical solution. Judge Bell also "dissolved" a temporary restraining order preventing the generic firms from introducing their products ("The Tan Sheet" April 22, p. 8).
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