External analgesic patches
This article was originally published in The Tan Sheet
Executive Summary
OTC "feedback" meeting scheduled for July 8. The meeting was requested by Hisamitsu Pharmaceutical to discuss a testing protocol for its methyl salicylate/menthol/camphor external analgesic patch. FDA asked Hisamitsu to submit safety and efficacy data at a 1994 feedback meeting for inclusion of the patch in the external analgesic final monograph. Hisamitsu submitted a protocol in 1995, and FDA responded with its concerns in 1996. The meeting is to be held at 1:30 p.m. at 9201 Corporate Blvd., Rockville, Md.; contact FDA's Valerie Miguele at (301) 827-2247 for more information. Hisamitsu markets the Salonpas patch in the U.S. in major chains including Walgreen and American Drug Stores. Mentholatum also markets a menthol external analgesic patch, Pain Patch. CNS pulled out of the external analgesic patch business June 30, ending its marketing agreement with Lec Tec for Therapatch...