Avenue Therapeutics Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA Tentatively Scheduled for February 15, 2022 [MarketWatch]
Avenue Therapeutics, Inc. (ATXI)
Last avenue therapeutics, inc. earnings: 8/14 07:30 am
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Company Research
Source: MarketWatch
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. About Avenue Therapeutics 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. Avenue is headquartered in New York
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ATXI
Sec Filings
- 4/17/24 - Form 4
- 4/17/24 - Form SC
- 3/29/24 - Form 8-K
- ATXI's page on the SEC website