Private label minoxidil

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