Heron Therapeutics: FDA grants Priority Review designation for NDA for HTX-011

Heron Therapeutics announced that the U.S. FDA has accepted the new drug application for Heron’s investigational agent, HTX-011, and has granted it a Priority Review designation. The NDA for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures. The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.
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