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
You may also be interested in...
Minoxidil delay
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
OCA Applauds Organic Board's Recommendation To USDA: "Outlaw Nanotech"
With a push from the Organic Consumers Association, the National Organic Standards Board is recommending that the use of nanotechnology be strictly prohibited from products certified under the National Organic Program