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Private label minoxidil

This article was originally published in The Tan Sheet

Executive Summary

Alpharma ANDA (75-518) for private label version of Pharmacia & Upjohn's Rogaine Extra Strength for Men tentatively approved July 22. Three-year marketing exclusivity for P&U's 5% minoxidil topical solution expires Nov. 14, 2000. At a July 29 American Academy of Dermatology meeting, Marty Sawaya, MD, University of Miami, noted hair loss treatments undergoing clinical trials include 5% minoxidil for women, for which P&U previously has said clinical trials have not shown significant effects. "We hope that by early next year 5% minoxidil [for women] will gain approval so that we can offer more treatment options," Sawaya said

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Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)

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