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In Brief: NDAC meeting

This article was originally published in The Tan Sheet

Executive Summary

NDAC meeting: FDA modifies agenda for March 27-28 meeting of its Nonprescription Drugs Advisory Committee to add two closed sessions. On the morning of March 27, NDAC and reps from the Pulmonary-Allergy Drugs Advisory Committee will discuss data on the efficacy of antihistamines to treat colds. This part of the meeting, originally scheduled for the afternoon of March 27, will begin at 10 a.m. NDAC and the Dermatologic Drugs Advisory Committee were scheduled to review J&J's switch NDA for econazole nitrate 1% (Spectazole) on the morning of March 27, but that meeting was postponed ("The Tan Sheet" Feb. 13, p. 2), and instead, a closed session for the NDAC committee has been added to the schedule for March 27 from 4-6 p.m. The agenda for March 28 remains the same with the addition of a closed session of NDAC and the Arthritis Advisory Committee from 11:30 a.m. to 12 noon. NDAC and the arthritis committee will review McNeil's switch application for Children's Motrin in the morning of March 28 and the "OTCness" of muscle relaxants that afternoon...
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