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Drug Safety Alerts
ZELNORM® Voluntary Withdrawal
6/30/2022
On June 30, 2022, Alfasigma USA, Inc. announced the withdrawal of the NDA for ZELNORM® (tegaserod) effective June 30th. Alfasigma USA, Inc. will no longer make the product available in the US marketplace.
This withdrawal affects all NDC’s and lot numbers of ZELNORM® (tegaserod).
According to Alfasigma, this decision was not based on product efficacy, safety or because of an imposed recall, but is strictly a business decision.
Patients will continue to have access to ZELNORM® (tegaserod) for as long as the existing supply of product remains in the trade channel. Alfasigma USA, Inc. urges patients and Health Care Providers to discuss alternative therapies that will meet patient needs.
CVS/Caremark® Response: Because of this action, CVS Caremark® Mail Service Pharmacy will reach out to impacted prescribers and patients.
For more information about this withdrawal, contact Alfasigma USA, Inc. Medical Information toll-free at 1-844-639-9726, 8:00 am to 5:00 pm (ET). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.