n South African Gastroenterology Review - FDA approves Zelnorm as the First Rx Therapy for Chronic Constipation

Volume 2, Issue 3
  • ISSN : 1812-1659



Extracted from text ... Novartis Pharma AG announced that the U.S. Food and Drug Administration (FDA) recently approved a supplemental indication for its pro-motility agent Zelnorm(r) (tegaserod maleate) for the treatment of chronic idiopathic constipation in male and female patients less than 65 years of age. The new indication is supported by safety and efficacy data from the two largest and longest randomized, double-blind, placebo-controlled , multinational Phase III clinical trials ever conducted in chronic constipation. The two three-month trials included more than 2, 600 male and female patients. In addition, one of the studies included a 13-month extension safety study of 840 patients. ..

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