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: 05 Apr 2018
At a glance
- Drugs Testosterone enanthate (Primary)
- Indications Hypogonadism
- Focus Adverse reactions; Registrational
- Acronyms STEADY
- Sponsors Antares Pharma
- 05 Apr 2018 According to an Antares Pharma media release, U.S. Food and Drug Administration acknowledged receipt of the company's March 29, 2018 resubmission to the Complete Response Letter in connection with the XYOSTED New Drug Application and considered it as complete. User fee goal date assigned as September 29, 2018.
- 27 Mar 2018 According to an Antares Pharma media release, official minutes from the Type A meeting with the U.S. FDA has been received. Based on the minutes, company expects to resubmit the re-analyses of existing data and expects to submit the complete response to FDA in the Q2 2018.
- 16 Jan 2018 According to an Antares Pharma media release, type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on February 21, 2018 for XYOSTED in response to the Complete Response Letter (CRL).