A 6-Month Safety Study of QuickShot Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
Phase of Trial: Phase III
Latest Information Update: 21 Dec 2017
At a glance
- Drugs Testosterone enanthate (Primary)
- Indications Hypogonadism
- Focus Adverse reactions; Registrational
- Acronyms STEADY
- Sponsors Antares Pharma
- 21 Dec 2017 According to an Antares Pharma media release, the company announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the U.S. Food and Drug Administration (FDA), in response to the Complete Response Letter (CRL).
- 20 Oct 2017 According to an Antares Pharma media release, the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for XYOSTED (testosterone enanthate) injection. The CRL indicates that the FDA cannot approve the NDA in its present form because the FDA is concerned that XYOSTED could cause a clinically meaningful increase in blood pressure and raised a concern regarding the occurrence of depression and suicidality.
- 27 Feb 2017 According to an Antares Pharma media release, New Drug Application (NDA) for QuickShot Testosterone (QST), been accepted for standard review by the U.S Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017.