Zelnorm treatment IND discontinued
Novartis has notified the FDA that Zelnorm (tegaserod maleate) will no longer be available under a treatment investigational New Drug Application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women <55 years of age. Novartis has agreed to continue to supply Zelnorm for use in emergency situations that are immediately life-threatening or serious enough to qualify for hospitalization. Requests for emergency Zelnorm may be made to the FDA who will in turn authorize the shipment of the drug by the manufacturer.
For more information call (888) NOW-NOVA or visit www.fda.gov/cder/drug/infopage/zelnorm/default.htm.