Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
NEW YORK, Feb. 13, 2020 (GLOBE NEWSWIRE) -- 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”) has accepted for review Avenue’s New Drug Application (“NDA”) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. The FDA set a Prescription Drug User Fee Act (“PDUFA”) goal action date of October 10, 2020.
“The NDA submission acceptance is another important step toward bringing IV tramadol to patients and their healthcare providers in the U.S.,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We look forward to working with the FDA as they evaluate our application.”
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