Avenue Therapeutics: FDA Still Reviewing NDA Resubmission - Quick Facts

(RTTNews) - Avenue Therapeutics, Inc. (ATXI) said the FDA was still reviewing its New Drug Application for IV tramadol. The NDA 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 had been assigned a PDUFA goal date of April 12, 2021.

Founded by Fortress Biotech, Inc. (FBIO), Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S.