Drug Development

Safety profile of naproxen detailed in U.S. FDA briefing document

Published in Medical Letter on the CDC and FDA, March 13th, 2005

Bayer HealthCare's Consumer Care Division said that an extensive briefing document analyzing the cardiovascular and cerebrovascular safety profile of naproxen had been filed with the U.S. Food & Drug Administration (FDA).

The briefing document, describing nearly 30 years of safe use of naproxen at both prescription and over-the-counter (OTC) dosages, was submitted in advance of the FDA's Arthritis and Drug Safety Advisory Committee Meeting. Bayer's naproxen sodium formulation has been sold as an OTC product under the trade name Aleve since 1994.

Bayer believes that its confidence in Aleve is well supported by the data in the briefing document and...

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Source: Medical Letter on the CDC and FDA (2005-03-13)

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