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# Antares NDA Resubmitted for Testosterone Replacement
- URL: https://www.fdaweb.com/antares-nda-resubmitted-for-testosterone-replacement/
- Published: 2018-04-05T12:00:00.000Z
- Updated: 2026-09-14T23:57:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141158

FDA has accepted an Antares Pharma NDA resubmission for Xyosted (testosterone enanthate) injection for testosterone replacement therapy. The NDA received a 10/2017 complete response letter that identified two deficiencies related to clinical data, according to the company. “Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned that Xyosted could cause a clinically meaningful increase in blood pressure,” it said at the time. “In addition, the letter also raised a concern regarding the occurrence of depression and suicidality.” FDA did not cite any chemistry, manufacturing and controls, device or efficacy issues related to Xyosted. The agency has set a 9/29 user fee review action date.