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Zelnorm constipation indication goes to advisory committee

Executive Summary

FDA's Gastrointestinal Drugs Advisory Committee will consider Novartis sNDA for use of Zelnorm in the treatment of chronic constipation at its July 14 meeting. Novartis submitted the chronic constipation sNDA on Oct. 21, 2003, giving the application a 10-month user fee deadline of Aug. 21. The meeting will take place in CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md., beginning at 8:30 a.m. [To watch a 1webcast or order a video/DVD of this meeting, go to FDAAdvisoryCommittee.com]...

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