Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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..

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts