Approved Risk Evaluation and Mitigation Strategies (REMS)

Axiron (testosterone)

NDA 022504
REMS last update: 07/13/2017

What is Axiron?

Why is Axiron required to have a REMS?

To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.