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NDAC

This article was originally published in The Tan Sheet

Executive Summary

Meeting scheduled Dec. 1 for the discussion of an NDA. The Sept. 10 meeting scheduled for the discussion of an NDA has been canceled, along with tentatively scheduled dates of Oct. 29-30. Possible candidates for discussion at the December meeting include SmithKline Beecham's Denavir for cold sores or McNeil's Nicotrol NS nasal spray or Nicotrol inhaler. On Sept. 11, the committee is meeting at 8:30 a.m. at the Holiday Inn in Bethesda, Md. to discuss class labeling for OTC vaginal antifungal drug products, for which the agency issued a guidance July 16 ("The Tan Sheet" July 20, p. 5). The committee's discussion of pediatric labeling for combination drug products has been postponed. NDAC's Dental Plaque Subcommittee is scheduled to meet Oct. 22-23 and Dec. 2-3 for a continuing discussion of issues related to the development of a monograph for OTC gingivitis/plaque products...
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