Zynrelef FDA Approval History
Last updated by Judith Stewart, BPharm on June 1, 2021.
FDA Approved: Yes (First approved May 12, 2021)
Brand name: Zynrelef
Generic name: bupivacaine and meloxicam
Dosage form: Injection
Previous Name: HTX-011
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 bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
- 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
|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|
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