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
You may also be interested in...
Minoxidil 5%
Alpharma began shipping generic version of hair regrowth treatment Nov. 18 following debut at Private Label Manufacturers Association trade show in Chicago Nov. 13-14. The 60 mL bottles will be sold in single-, double- and triple-packs and will retail for $14.99-$19.99 per bottle, the company says. ANDAs for the topical solution submitted by Alpharma (75-518) and Copley (75-619) cleared FDA on Nov. 17; Pharmacia's Rogaine Extra Strength for Men lost exclusivity Nov. 14. Perrigo also plans to offer generic version of minoxidil 5%, but was forced to delay shipping until April due to an unfavorable FDA inspection of its Allegan, Mich. facility (1"The Rose Sheet" Nov. 6, In Brief)
Minoxidil 5%
Alpharma began shipping generic version of hair regrowth treatment Nov. 18 following debut at Private Label Manufacturers Association trade show in Chicago Nov. 13-14. The 60 mL bottles will be sold in single-, double- and triple-packs and will retail for $14.99-$19.99 per bottle, the company says. ANDAs for the topical solution submitted by Alpharma (75-518) and Copley (75-619) cleared FDA on Nov. 17; Pharmacia's Rogaine Extra Strength for Men lost exclusivity Nov. 14. Perrigo also plans to offer generic version of minoxidil 5%, but was forced to delay shipping until April due to an unfavorable FDA inspection of its Allegan, Mich. facility (1"The Rose Sheet" Nov. 6, In Brief)
Private label minoxidil
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