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# Fortesta Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/fortesta-not-withdrawn-due-to-safety-efficacy/
- Published: 2024-11-20T12:00:00.000Z
- Updated: 2026-09-14T14:47:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158224

*Federal Register* notice: FDA has determined that Endo’s Fortesta (testosterone) gel, 10 mg/0.5 g, was not withdrawn due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Fortesta is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-20/pdf/2024-27103.pdf?ref=fdaweb.com).