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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 email@example.com 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
Attention Female Alosetron medication users: The Alosetron Risk Evaluation and Mitigation Strategies (REMS) Program is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product. The manufacturers/sponsors of the program have a regulatory obligation to conduct a knowledge survey for female patients in the US who have taken alosetron within the last twelve months. Patients that meet the criteria for inclusion in the survey will receive $50 for completing the survey. The survey takes about 30 minutes and can be taken either online or by phone with a call center representative. Survey responses are aggregated and anonymized. No protected health information is required for the survey or provided to FDA or any prescribers. The survey opens on January 3, 2018. If you are a female patient in the US who has taken alosetron within the last twelve months, please call us at 1-844-267-8675 to take the survey. Sincerely, The Alosetron REMS Program Sponsors