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
|Dec 9, 2021||Approval Heron Therapeutics Announces FDA Approval of an Indication Expansion for Zynrelef for Postoperative Pain Management|
|May 13, 2021||Approval FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain|
|Jan 21, 2021||Heron Therapeutics Announces Publication of Results from EPOCH 1 Follow-On Study of HTX-011 in Patients Undergoing Bunionectomy Surgery|
|Nov 13, 2020||Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain|
|Jun 29, 2020||Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain|
|Feb 19, 2020||Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain|
|Oct 28, 2019||Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain|
|Oct 1, 2019||Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain|
|May 1, 2019||Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain|
|Dec 31, 2018||FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management|
|Oct 31, 2018||Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management|
|Mar 19, 2018||Heron Announces Positive Topline Results From Pivotal Phase 3 Clinical Trials of HTX-011 in Bunionectomy and Hernia Repair|
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