FDA Approves marketing of ZELNORM (07/24/02)

Open Letter to the FDA About Zelnorm link

Zelnorm Action Group

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ACTION ITEMS: An URGENT APPEAL TO CONGRESS: link Send your personal story to: Lester Crawford Jr., DVM, Ph.D. Deputy Commissioner Food and Drug Administration Email: lcrawford@oc.fda.gov Janet Woodcock Director CDER Food and Drug Administration Email: woodcockj@cder.fda.gov Send your personal story to counter the claims made by Public Citizen (http://www.citizen.org/hrg/PUBLICATIONS/1561.htm) FDA Dockets Management Branch 5630 Fishers Lane Room 1061 HFA-305 Rockville, MD 20852 Docket# 01P-0259 Contact Novartis 1-800-NOW-NOVA or 973-781-8300 and remind them how badly you want this drug. Send your personal letters to: Florence Houn: hounf@cder.fda.gov Victor Raczkowski: raczkowskiv@cder.fda.gov Lilia Talarico: talarico@cder.fda.gov Hugo Gallo-Torres: gallotorresh@cder.fda.gov Evelyn Rodriguez: rodrigueze@cder.fda.gov Nancy Ostrove: ostrove@cder.fda.gov Stephen Hanauer: shanauer@medicine.bsd.uchicago.edu Loren Laine: llaine@hsc.usc.edu George Ferry: gastroenterologynutrition@texaschildrenshospital.o Christina Surawicz: surawicz@u.washington.edu Michael Wolfe: mwolfe@bu.edu

Support and information about the drug Zelnorm (Zelmac),  tegeaserod, marketed by Novartis

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NEWS: Novartis in advanced discussions with FDA and is preparing for a launch in the US this year Analysis Shows Favorable Effects of Tegaserod in Treating IBS-C Zelnorm approved for marketing in Canada and Brazil Study presented at International Medical Meeting reinforces long-term safety of Novartis' Zelmac for treatment of IBS Alimentary Pharmacology & Theraputics Study: Zelnorm is safe and effective for IBS Novartis to appeal FDA "not approvable" letter for Zelnorm Novartis launches irritable bowel syndrome treament Zelmac in first market, Mexico FDA Requests More  Data in order to Approve Zelnorm FDA Rejects New Drug for Irritable Bowel Syndrome

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Last Updated: February 19, 2004 Founded By: Jeffrey Roberts

RESOURCES: Zelnorm Action Group email list IBS Self Help and Support Group Zelnorm.com