Fortress Biotech Inc

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Avenue Therapeutics Receives Complete Response Letter From The FDA For IV Tramadol

Published: 06/14/2021 14:00 GMT
Fortress Biotech Inc (FBIO) - Avenue Therapeutics Receives Complete Response Letter From the FDA for Iv Tramadol.
Avenue Therapeutics Inc - FDA Did Not Identify Any Chemistry, Manufacturing and Controls Issues in This Crl.
Avenue Therapeutics - Disagrees With FDA's Interpretation of Data in NDA and Intends to Continue to Pursue Regulatory Approval for Iv Tramadol.
Avenue Therapeutics - Crl Stated Delayed, Unpredictable Onset of Analgesia With Iv Tramadol Does Not Support Benefit As Monotherapy to Treat Patients in Acute Pain.
Avenue Therapeutics - Crl Stated There is Insufficient Info to Support Iv Tramadol With Other Analgesics is Safe, Effective for Intended Patient Population.