Benzinga | Nov 29, 2021 08:03AM EST

Avenue Therapeutics Announces FDA Advisory Committee Meeting To Review IV Tramadol NDA Tentatively Scheduled For February 15, 2022

Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue" or the "Company"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that the FDA has informed the Company that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee is tentatively scheduled for February 15, 2022. The committees will discuss the IV tramadol New Drug Application.

The FDA has previously stated that input from an Advisory Committee is needed for the Office of New Drugs ("OND") to reach a decision on Avenue's formal dispute resolution request and that the OND will respond to Avenue's appeal within 30 calendar days after the Advisory Committee meeting.