Posted by Michael Wonder on 17 Jul 2019
Durect announces that the FDA agreed to file the full response to the Posimir complete response letter as a complete Class 2 resubmission
17 July 2019 - User fee goal date is 27 December 2019.
Durect Corporation today announced that the U.S. FDA has acknowledged that the submission of Durect's full response to the complete response letter it previously received from FDA related to Posimir (bupivacaine extended-release solution) is considered by the FDA to be a complete class 2 response to the letter. The user fee goal date is 27 December 2019.
The submission is intended to address the issues raised in the letter and seeks FDA approval of Posimir based on what the Company and its advisors believe is adequate evidence of both safety and efficacy.
