Rogaine 5% minoxidil solution targeted only to men due to lack of data in women.
This article was originally published in The Tan Sheet
Executive Summary
ROGAINE EXTRA STRENGTH "NOT FOR USE BY WOMEN" HIGHLIGHTED IN LABELING proposed by Pharmacia & Upjohn for the anti-baldness treatment. The company is attempting to gain approval for Rogaine 5% minoxidil solution as a direct-to-OTC product. The NDA (20-834) was the topic of a July 16 joint meeting of FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committees in Bethesda, Md.