Novartis Zelnorm Approval: FDA Accepts Overseas History, Active Surveillance
Executive Summary
The approval of Novartis' Zelnorm reflects FDA's comfort with an active surveillance program proposed by the company - and the extensive post marketing safety database of the irritable bowel syndrome agent in overseas markets
You may also be interested in...
Novartis To Assess Zelnorm “Medguide” Distribution In Phase IV Study
Novartis will create a protocol to assess the distribution of the Zelnorm "Medguide" to patients as one Phase IV commitment following FDA approval of a chronic idiopathic constipation indication
Novartis To Assess Zelnorm “Medguide” Distribution In Phase IV Study
Novartis will create a protocol to assess the distribution of the Zelnorm "Medguide" to patients as one Phase IV commitment following FDA approval of a chronic idiopathic constipation indication
Novartis Revises Zelnorm Labeling With Diarrhea, Ischemic Colitis Risk Info
Novartis has revised labeling for the irritable bowel syndrome therapy Zelnorm to include the risk of developing severe diarrhea and ischemic colitis, FDA says in a 1"Talk Paper" issued April 28