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Hisamitsu Salonpas analgesic patch comparison to other dosage forms needed -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

SALONPAS ANALGESIC PATCH COMPARISON TO OTHER DOSAGE FORMS needed before FDA can render a full decision on the product's safety and efficacy, FDA Division of OTC Drugs Deputy Director Linda Katz, MD, said at an OTC "feedback" meeting in Rockville, Md. July 8. Determining how Salonpas' safety and efficacy profile compares to other approved vehicles for external analgesics, such as ointments, "is the crux of the concern, because without being able to say where your product fits in as a patch, we don't know that information," Katz said. "So that's the missing part of the puzzle" that was being requested by FDA in an October 1996 feedback letter, she added.
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