ZELMAC (tegaserod)

3/16/01


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Table of Contents

ZELMAC (tegaserod)

Zelmac Background

Zelmac NDA Submission

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Phase III Trials -2521 Pts Similarities

Phase III Trials

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Efficacy Issues

Abdominal Pain

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Overall Efficacy 8-11 %

Efficacy in Males

Laxative Use

Efficacy Summary

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Safety in General n =1679

Safety (Cont.)

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Diarrhea

Possible Ovarian Cysts

Pts Undergoing Surgery

Case No. 1 (12 mg)

Case No. 2 (12 mg)

Case No. 3 (12 mg)

Case No. 4 (12 mg)

Case No. 5 (12mg)

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Ovarian Cysts In Ongoing Studies

Safety Summary

Author: CDER User