Posted by Michael Wonder on 05 Mar 2020
Trevena announces FDA has set PDUFA date of 7 August 2020 for oliceridine
5 March 2020 - FDA considers NDA resubmission a complete Class 2 response.
Trevena today announced that the U.S. FDA has acknowledged receipt of the resubmitted new drug application for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain.
In their acknowledgement letter, FDA stated that the Company’s resubmission is a complete, Class 2 response to the Agency’s action letter dated 2 November 2018. A Prescription Drug User Fee Act goal date has been set for 7 August 2020.
