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Zynrelef FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 13, 2021.

FDA Approved: Yes (First approved May 12, 2021)
Brand name: Zynrelef
Generic name: bupivacaine and meloxicam
Dosage form: Injection
Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

Zynrelef (bupivacaine and meloxicam) is an extended-release, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam indicated for the management of postoperative pain.

  • Zynrelef is indicated for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.
  • As Zynrelef contains the NSAID meloxicam, the product label carries a boxed warning for an increased risk of cardiovascular and gastrointestinal events.
  • Common side effects include constipation, vomiting, and headache.

Development timeline for Zynrelef

DateArticle
Dec  9, 2021Approval Heron Therapeutics Announces FDA Approval of an Indication Expansion for Zynrelef for Postoperative Pain Management
May 13, 2021Approval FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain
Jan 21, 2021Heron Therapeutics Announces Publication of Results from EPOCH 1 Follow-On Study of HTX-011 in Patients Undergoing Bunionectomy Surgery
Nov 13, 2020Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.