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In Brief: Aleve

This article was originally published in The Tan Sheet

Executive Summary

Aleve: Phase IV clinical study on efficacy of the OTC naproxen sodium analgesic for headache has been accepted by FDA. The Procter-Syntex product was approved by FDA with the general analgesic indications, including headache, in January 1994 with the understanding that the firm would conduct postmarket studies to comply with future agency changes to OTC analgesic requirements. In January 1995, FDA announced that separate studies for headache, dysmenorrhea and fever would be required before analgesics could make those claims ("The Tan Sheet" Jan. 16, p. 1). The changes grew out of the Aleve advisory committee review in June 1993 ("The Tan Sheet" June 7, 1993, p. 5). Separately, P&G introduced Aleve in the Puerto Rican market July 18..

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