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Minoxidil delay

This article was originally published in The Rose Sheet

Executive Summary

Perrigo's private-label minoxidil 5% November launch precluded due to corrective actions taken in response to unfavorable FDA inspection of Perrigo's Allegan, Mich. facility, firm says. Perrigo had hoped to introduce minoxidil 5% immediately following the Nov. 14 expiration of Pharmacia's exclusivity for Rogaine Extra Strength; Copley Pharmaceutical and Alpharma already have received tentative approvals (1"The Rose Sheet" Feb. 7, In Brief). Perrigo expects its global action plan to reform the plant's quality control system and enable full resumption by FY 2002 (begins July 1). FDA's Detroit district investigators uncovered cGMP violations during mid-year inspection
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