"Faster onset of action" claim for S(+)ibuprofen could inform consumers, cmte. notes.
This article was originally published in The Tan Sheet
Executive Summary
S(+)IBUPROFEN "FASTER ONSET OF ACTION" CLAIM would provide useful information to consumers, several members and consultants to FDA's Nonprescription Drugs and Arthritis Drugs Advisory Committees agreed at an Oct. 9 joint meeting. Bayer is claiming that S(+)ibuprofen, or dexibuprofen, has a faster onset than racemic, or regular, ibuprofen. The joint advisory committee decided at the one-day meeting not to recommend that FDA approve Bayer's NDA for dexibuprofen as an OTC nonsteroidal anti-inflammatory drug based on Bayer's submitted safety and efficacy data.