Perrigo New Product Program, Quality Control Back On Track In FY 2002
This article was originally published in The Tan Sheet
Executive Summary
Corrective actions taken in response to an unfavorable FDA inspection of Perrigo's Allegan, Mich. facility will preclude the planned November launch of minoxidil 5% and stall the company's pipeline, Perrigo told analysts in an Oct. 25 conference call.
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Minoxidil
ANDAs for minoxidil topical solution 5% submitted by Alpharma (75-518) and Copley Pharmaceuticals (75-619) were approved by FDA Nov. 17; Pharmacia's Rogaine Extra Strength for Men lost market exclusivity Nov. 14. Alpharma, which debuted its generic version of the hair regrowth treatment at the Private Label Manufacturers Association annual trade show in Chicago Nov. 13-14, began shipping the product Nov. 18. The 60 mL bottles will be sold in single-, double- and triple-packs and will retail for between $14.99 and $19.99 per bottle, the company says. Perrigo also plans to offer a generic version of minoxidil 5%, but was forced to push back the shipping date until April due to an unfavorable FDA inspection of its Allegan, Mich. facility (1"The Tan Sheet" Oct. 30, p. 13)