Pharmacia & Upjohn Rogaine 5% new clinical trials in women to begin shortly.
This article was originally published in The Rose Sheet
Executive Summary
P&U PURSUING SEPARATE APPROVAL OF ROGAINE EXTRA STRENGTH FOR WOMEN with data from additional clinical trials that are slated to begin shortly, the company said at a July 16 joint meeting of FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committees in Bethesda, Md. Pharmacia & Upjohn first attempted to gain approval for use of 5% minoxidil solution in both men and women but results from the initial round of clinical trials did not show statistically significant efficacy in women. The committees voted to recommend approval for Rogaine Extra Strength for use by men for the indication "more hair regrowth" ("The Rose Sheet" July 21, p. 5).