Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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testosterone 1.62% (ANDA 204268) (testosterone)
ANDA #204268
REMS last update: 08/04/2015



What is the purpose of the REMS?

To inform patients about the serious risks associated with the use of testosterone gel.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s).

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the testosterone 1.62% (ANDA 204268) REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/testosterone_1.62_gel_2015.08.04_REMS_document.pdf

What updates have been made to the REMS?

Date Summary of change
08/04/2015 Approval of the REMS.

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.

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