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NDAC to consider Beconase switch, pediatric analgesic dosing at September meeting.

This article was originally published in The Tan Sheet

Executive Summary

BECONASE Rx-TO-OTC SWITCH REVIEW BY FDA's NDAC, PULMONARY-ALLERGY advisory committees is scheduled for Sept. 19. FDA's Nonprescription Drugs Advisory Committee, meeting jointly with the agency's Pulmonary-Allergy Drugs Advisory Committee, will consider NDA 20-840 for beclomethasone dipropionate nasal spray .042%. The switch NDA was filed by Glaxo Wellcome in December 1996 for the OTC treatment and prevention of seasonal allergic rhinitis symptoms in individuals over the age of 12. Glaxo will present studies in support of the switch of the product; however, if approved for OTC sale, Beconase will be marketed by Warner-Lambert under the companies' Rx-to-OTC switch joint venture.

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