Avenue Therapeutics, Inc. (NASDAQ: ATXI) saw its shares slide early Monday, on word Washington was still hemming and hawing over its New Drug Application.
Avenue, a company focused on the development of intravenous tramadol for the U.S. market, today announced that the U.S. Food and Drug Administration was still reviewing its New Drug Application as of last week for IV tramadol and had not provided a decision regarding the NDA.
An acknowledgement letter from the FDA in February stated that the Company’s resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act goal date of April 12, 2021.
The NDA for IV tramadol 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 package included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
Avenue Therapeutics says its 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 City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).
ATXI shares lost 17 cents, or 3.7%, to $4.37.
Related Stories
