FDA on OTC switches
This article was originally published in The Tan Sheet
Executive Summary
Rx-to-OTC switches "are not on the ropes," FDA Office of Drug Evaluation I Director Robert Temple, MD, said at a Dec. 6 briefing with trade press, despite recent FDA advisory committee recommendations against approval of OTC switches for the baldness remedy Rogaine and the H[2] antagonists cimetidine and famotidine. "You shouldn't assume that [those switches] are not going anywhere," Temple said. He added that the committee recommendations "were perceived as much more adverse" than they actually are