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# Axiron Not Withdrawn Over Safety/Efficacy
- URL: https://www.fdaweb.com/axiron-not-withdrawn-over-safety-efficacy/
- Published: 2018-11-08T12:00:00.000Z
- Updated: 2026-09-15T00:43:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142779

*Federal Register* notice: FDA has determined that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. Axiron was initially approved in 2010 for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. In 2017, Lilly requested withdrawal of the NDA. The agency determination was made in response to a citizen petition received earlier this year. It allows FDA to approve ANDAs that refer to the drug product as long as they meet all other legal and regulatory requirements. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-24604.pdf?ref=fdaweb.com).