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Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for Zelnorm


Jeffrey Roberts
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Jeffrey Roberts

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There will be a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee at the Food and Drug Administration (FDA) on October 17, 2018.

Agenda: The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

The IBS Patient Group will be submitting a comment for the public docket for this meeting. If you have experience with Zelnorm for IBS-C or CIC when it was first marketed by Novartis Pharma in 2002 - 2007, we would like to hear from you. Please email us at ibs@ibspatient.org or add your comments below.

https://www.federalregister.gov/documents/2018/09/11/2018-19669/joint-meeting-of-the-gastrointestinal-drugs-advisory-committee-and-the-drug-safety-and-risk



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