NDA 21-200, Zelmac (tegaserod) Novartis Pharmaceuticals Corporation pdf doc

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document

Division of Gastrointestinal and Coagulation Drug Products, Preliminary Medical/Statistical Review pdf   First 17 pages only  doc