Posted by Michael Wonder on 13 Apr 2021
Avenue Therapeutics announces that the FDA is still reviewing its NDA resubmission for IV tramadol
13 April 2021 - The FDA has not provided a decision regarding the new drug application.
Avenue Therapeutics today announced that the U.S. FDA was still reviewing its new drug application for IV tramadol and had not provided a decision regarding the new drug application.
An acknowledgement letter from the FDA in February 2021 stated that the Company’s resubmission of its new drug application for IV tramadol was a complete, class 1 response to the complete response letter dated 9 October 2020 and the resubmission had been assigned a Prescription Drug User Fee Act goal date of 12 April 2021.
