Benzinga | Apr 13, 2021 06:32AM EDT

Avenue Therapeutics Announces FDA Is Still Reviewing Its NDA Resubmission For IV Tramadol And has Not Provided Decision

Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that the U.S. Food and Drug Administration ("FDA") was still reviewing its New Drug Application ("NDA") for IV tramadol and had not provided a decision regarding the NDA.



An acknowledgement letter from the FDA in February 2021 stated that the Company's resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter ("CRL") dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act ("PDUFA") goal date of April 12, 2021.

The NDA for IV tramadol was resubmitted following the receipt of official minutes from a Type A meeting with the FDA, which was conducted following a CRL issued by the FDA in October 2020. The resubmission package included revised language relating to the proposed product label and a report relating to terminal sterilization validation.