Avenue Therapeutics, Inc. (ATXI) said the FDA was still reviewing its New Drug Application for IV tramadol. The NDA 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 had been assigned a PDUFA goal date of April 12, 2021.

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Avenue Therapeutics, Inc. (ATXI) said the FDA was still reviewing its New Drug Application for IV tramadol. The NDA 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 had been assigned a PDUFA goal date of April 12, 2021.

RTTNews | Apr 13, 2021 06:51AM EDT

06:51 Tuesday, April 13, 2021 (RTTNews.com) - Avenue Therapeutics, Inc. (ATXI) said the FDA was still reviewing its New Drug Application for IV tramadol. The NDA 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 had been assigned a PDUFA goal date of April 12, 2021.

Founded by Fortress Biotech, Inc. (FBIO), 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.

Read the original article on RTTNews ( https://www.rttnews.com/3184451/avenue-therapeutics-fda-still-reviewing-nda-resubmission-quick-facts.aspx)

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