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HTX-011 FDA Approval Status

FDA Approved: No
Brand name: HTX-011
Generic name: bupivacaine and meloxicam
Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

HTX-011 (bupivacaine and meloxicam) is an investigational fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in development for the management of postoperative pain.

Development Timeline for HTX-011

DateArticle
Jun 29, 2020Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain
Feb 19, 2020Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
Oct 28, 2019Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain
Oct  1, 2019Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain
May  1, 2019Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain
Dec 31, 2018FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Oct 31, 2018Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
Mar 19, 2018Heron Announces Positive Topline Results From Pivotal Phase 3 Clinical Trials of HTX-011 in Bunionectomy and Hernia Repair

Further information

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