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Novartis To Assess Zelnorm “Medguide” Distribution In Phase IV Study

Executive Summary

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

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Novartis Zelnorm patient information (correction)

Novartis has agreed to assess the distribution of patient prescribing information as a Phase IV commitment required for approval of its chronic constipation indication. "The Pink Sheet" had incorrectly reported that the company would assess the distribution of Zelnorm "Medguides" (1"The Pink Sheet" Aug. 30, 2004, p. 8). Zelnorm is not required to be distributed with a Medguide...

Novartis Zelnorm patient information (correction)

Novartis has agreed to assess the distribution of patient prescribing information as a Phase IV commitment required for approval of its chronic constipation indication. "The Pink Sheet" had incorrectly reported that the company would assess the distribution of Zelnorm "Medguides" (1"The Pink Sheet" Aug. 30, 2004, p. 8). Zelnorm is not required to be distributed with a Medguide...

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