FDA Events for Heron Therapeutics (HRTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Heron Therapeutics (HRTX).
Over the past two years, Heron Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ZYNRELEF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ZYNRELEF (bupivacaine and meloxicam HTX-011) - FDA Regulatory Timeline and Events
ZYNRELEF (bupivacaine and meloxicam HTX-011) is a drug developed by Heron Therapeutics for the following indication: Postoperative pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- September 25, 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN.
AI Summary
Heron Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved its Prior Approval Supplement Application for the ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. This new design will replace the current vented vial spike and features a user-friendly “container-like” design that simplifies aseptic preparation. The VAN significantly reduces the withdrawal time for ZYNRELEF to just 20 to 45 seconds, making it easier and faster for surgical staff to prepare and use during procedures.
The streamlined design is expected to boost the safe use and adoption of ZYNRELEF, addressing a key hurdle in its current application. With a planned launch in Q4 2024, this approval aims to improve postoperative care by decreasing patient pain during recovery following various surgical procedures.
Read Announcement- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- September 25, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc. announced that The VAN is expected to launch in Q4 2024
AI Summary
Heron Therapeutics announced that its new device, the VAN, is expected to launch in Q4 2024. The VAN is designed to make the preparation of ZYNRELEF easier by replacing the current vented vial spike. Its innovative, “container-like” design simplifies aseptic preparation and reduces the withdrawal time for ZYNRELEF to between 20 and 45 seconds.
This advancement is aimed at helping surgical staff save time and improve the safe use of the medication during operations. With a user-friendly design, the VAN is anticipated to boost adoption rates and provide healthcare professionals with a more effective method for managing postoperative pain, which is critical for patient recovery. The company’s focus on innovation continues to drive its efforts toward enhancing surgical care and patient outcomes.
Read Announcement- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- July 15, 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc. announced that ZYNRELEF® (bupivacaine and meloxicam) is included in the proposed 2025 Non-Opioid Policy for Pain Relief under the Medicare hospital Outpatient Prospective Payment System ("OPPS") and the Medicare Ambulatory Surgical Center ("ASC") payment system (the "Proposed Rule") as a qualifying product effective April 1, 2025.
AI Summary
Heron Therapeutics, Inc. announced that its product, ZYNRELEF® (a fixed-dose combination of bupivacaine and meloxicam), has been included in the proposed 2025 Non-Opioid Policy for Pain Relief. The policy, issued by the Centers for Medicare and Medicaid Services, covers both the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) payment system, with an effective date of April 1, 2025.
This inclusion recognizes ZYNRELEF’s role in managing postoperative pain while potentially reducing or eliminating opioid use. Currently, ZYNRELEF is reimbursed through a pass-through payment status which is set to expire on March 31, 2025. Under the proposed rule, the product is expected to continue receiving separate reimbursement in both hospital outpatient and ASC settings, and for 2025, payments will remain at average sales price plus six percent, supporting stable access for patients and providers.
Read Announcement- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- July 2, 2024
- Estimated Event Date Range:
- September 23, 2024 - September 23, 2024
- Target Action Date:
- September 23, 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc announced that . The FDA has assigned a PDUFA goal date of September 23, 2024.
AI Summary
Heron Therapeutics, Inc. announced that the FDA has acknowledged receipt of its Prior Approval Supplement application regarding the ZYNRELEF® extended-release solution, known as the VAN. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 23, 2024, for its review. If approved, the VAN will replace the current vented vial spike, simplifying the aseptic preparation process. The new design can also reduce ZYNRELEF’s withdrawal time from up to three minutes to only twenty to forty-five seconds, potentially offering a safer and more user-friendly option for healthcare professionals.
This streamlined process may boost adoption among surgeons, as it enhances the overall ease of use. With the regulatory review in progress, Heron Therapeutics remains optimistic about meeting the target deadline and advancing the innovative delivery system for improved surgical outcomes.
Read Announcement- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- July 2, 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc. announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement ("PAS") application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN.
AI Summary
Heron Therapeutics, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its Prior Approval Supplement (PAS) application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. This step is critical for the Company, as the VAN could soon replace the current vented vial spike used with ZYNRELEF. The new device is designed to simplify the aseptic preparation process while significantly reducing drug withdrawal time—from as long as three minutes to between twenty and forty-five seconds. The user-friendly “container-like” design is expected to enhance the safety and ease of use of ZYNRELEF, potentially boosting its adoption in clinical settings. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 23, 2024, aiming for the device’s market availability later this year.
Read Announcement- Drug:
- ZYNRELEF (bupivacaine and meloxicam HTX-011)
- Announced Date:
- May 29, 2024
- Indication:
- Postoperative pain
Announcement
Heron Therapeutics, Inc. announced the Prior Approval Supplement ("PAS") submission to the U.S. Food and Drug Administration ("FDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN").
AI Summary
Heron Therapeutics, Inc. announced that it has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for its ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle (VAN). The company expects to receive an action date within the next several weeks and anticipates an FDA review period of four to six months.
The new VAN is designed to replace the current vented vial spike (VVS) in the ZYNRELEF kit. It could greatly reduce the product withdrawal time from up to three minutes to just 20–45 seconds. This improvement simplifies the sterile preparation process and enhances safety and ease of use, which may help clinicians deliver more efficient postoperative pain relief.
Read Announcement
Heron Therapeutics FDA Events - Frequently Asked Questions
As of now, Heron Therapeutics (HRTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Heron Therapeutics (HRTX) has reported FDA regulatory activity for ZYNRELEF (bupivacaine and meloxicam HTX-011).
The most recent FDA-related event for Heron Therapeutics occurred on September 25, 2024, involving ZYNRELEF (bupivacaine and meloxicam HTX-011). The update was categorized as "FDA Approval," with the company reporting: "Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN."
Currently, Heron Therapeutics has one therapy (ZYNRELEF (bupivacaine and meloxicam HTX-011)) targeting the following condition: Postoperative pain.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:HRTX) was last updated on 7/10/2025 by MarketBeat.com Staff
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