The manufacturer plans to continue discussions with the FDA to pursue approval.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
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References
- Avenue Therapeutics. News release: Avenue Therapeutics announces positive topline phase 3 data for intravenous tramadol in the management of postoperative pain. 2018 May 21.
- Recro Pharma Inc. News release: Recro Pharma receives complete response letter from the FDA. 2018 May 24.