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Chlorzoxazone/acetaminophen

Executive Summary

FDA notifies 62 firms through July 27 reg letter to cease marketing the skeletal muscle relaxant combination product pursuant to an April 27 Federal Register notice withdrawing portions of the NDA that provides for Parafon Forte tablets (McNeil) containing chlorzoxazone 250 mg and acetominophen 300 mg. The action stems from a DESI ruling that the combination lacks substantial evidence of efficacy.
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PS016067

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