Posted by Michael Wonder on 20 Oct 2017
Antares Pharma receives complete response letter from the FDA for Xyosted
20 October 2017 - Antares Pharma announced that today it has received a complete response letter from the U.S. FDA regarding the new drug application for Xyosted (testosterone enanthate) injection.
The CRL indicates that the FDA cannot approve the application in its present form.
The CRL identified two deficiencies related to clinical data. 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. In addition, the letter also raised a concern regarding the occurrence of depression and suicidality. The CRL did not cite any chemistry, manufacturing and controls, device or efficacy issues with regard to Xyosted. The next step will be to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon a path forward for a potential approval of Xyosted.
