Benzinga | Oct 25, 2021 07:10AM EDT

Avenue Therapeutics Receives Interim Response To Its Formal Dispute Resolution Request From US Food And Drug Administration Office Of New Drugs

Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that it has received a written interim response from the Office of New Drugs ("OND") of the U.S. Food and Drug Administration ("FDA"). The letter indicated that the OND needs additional input from an Advisory Committee in order to reach a decision on the Formal Dispute Resolution Request ("FDRR"), the details of which have previously been disclosed.



Accordingly, the FDA will convene an Advisory Committee meeting and seek advice from the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The letter stated that the OND will respond to the FDRR within 30 calendar days after the Advisory Committee meeting.