Trial Profile

A third phase III safety and pharmacokinetics study to of HTX-011

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 15 Jan 2021

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At a glance

11 Jan 2021 According to a Heron Therapeutics media release, the New Drug Application (NDA) was resubmitted to the U.S. FDA for HTX-011, for the management of postoperative pain. This resubmission is under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.
19 Feb 2020 According to an Heron Therapeutics media release, the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for HTX-011 by up to three months. The new PDUFA goal date is June 26, 2020.
14 Aug 2017 New trial record

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