Rx Rogaine study on hemodynamic effects provided sufficient OTC safety data -- Temple.
This article was originally published in The Tan Sheet
Executive Summary
Rx ROGAINE STUDY OUTLINING TOPICAL MINOXIDIL DOSE/RESPONSE versus oral minoxidil, "six benign...years of marketing," and a post-marketing study "indicate a very satisfactory record of safety...suitable for an OTC drug," FDA Office of Drug Evaluation I Director Robert Temple, MD, concluded in a March 20 memo. Addressed to Center for Drug Evaluation and Research Director Janet Woodcock, MD, the 19-page memo outlines Temple's thoughts on why an I.V. minoxidil safety study conducted by Upjohn in support of the Rogaine switch was not essential for FDA approval.