Private label minoxidil
This article was originally published in The Rose Sheet
Executive Summary
FDA tentatively approves Copley Pharmaceutical ANDA 75-619 for minoxidil 5% on Jan. 18. The reference drug, Pharmacia & Upjohn's Rogaine Extra Strength for Men, loses market exclusivity Nov. 14, 2000. The ANDA is the second for 5% minoxidil to be tentatively cleared by the agency; Alpharma received tentative approval on July 22. Perrigo also has filed an ANDA for the product