Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 2/3/17

Axiron (testosterone) Topical Solution REMS

Goals of the Axiron (testosterone) Topical Solution REMS Program

To inform patients about the serious risks associated with the use of AXIRON (testosterone) topical solution and its authorized generic.

REMS Elements

• Medication Guide

REMS Summary of Terms