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In Brief: Copley Pharmaceutical

This article was originally published in The Tan Sheet

Executive Summary

Copley Pharmaceutical: Asks FDA not to grant three-year market exclusivity to Pharmacia & Upjohn for the sale of OTC Rogaine baldness treatment in a recent letter. Copley was close to having its generic minoxidil product approved for prescription sale when Rogaine achieved OTC status on Feb. 12; since then, Copley said, the company has been preparing new labeling and packaging to reflect the switch. Copley noted that it would be "severely prejudiced if the FDA permits Upjohn to continue to exploit procedural devices to extend its control over the sale of minoxidil." Copley's letter supports a citizen petition previously filed by Hyman, Phelps & McNamara...

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