Posted by Michael Wonder on 06 Apr 2018
Antares Pharma provides Xyosted regulatory update
5 April 2018 - Complete response resubmission accepted – PDUFA date 29 September 2018.
Antares Pharma today announced that the U.S. FDA has acknowledged receipt of the company’s 29 March 2018 resubmission to the complete response letter received in connection with the Xyosted (testosterone enanthate subcutaneous injection) new drug application.
The FDA considered this resubmission a complete, class 2 response and has assigned a user fee goal date of 29 September 2018.
