In Brief: OTC Rogaine
This article was originally published in The Rose Sheet
Executive Summary
OTC Rogaine: Will be available on store shelves in early April following FDA approval of the baldness remedy on Feb. 9. The company will offer both Rogaine for Men in blue packaging and Rogaine for Women in salmon-colored containers. Except for the packaging, the OTC formula, which includes 2% minoxidil, will be identical to prescription Rogaine. After failing to clear the proposed switch during its first review of Upjohn's application in July 1994, FDA's Nonprescription Drugs Advisory Committee recommended approval of the OTC switch at a subsequent meeting in November 1995 after seeing several new studies that tested consumer use and label comprehension ("The Rose Sheet" Nov. 27, p. 8)...