Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 5/11/15 12:00 AM EDT

AndroGel (testosterone gel) 1% REMS

Goal of the AndroGel (testosterone gel) 1% REMS Program

To inform patients about the serious risks associated with the use of AndroGel (testosterone gel) 1%.

REMS Elements

• Medication Guide

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REMS Summary of Terms