Heron Acceptance of Prior Approval Supplement Application for Vial Access Needle

 -The U.S. Food and Drug Administration ("FDA") assigned a Prescription Drug User Fee Act ("PDUFA") goal date of September 23, 2024

Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today 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. The FDA has assigned a PDUFA goal date of September 23, 2024.

If approved, the introduction of the VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time from up to three minutes down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. If approved, the VAN is expected to be available for use in the fourth quarter of this year.

In addition to the anticipated launch of the VAN, the national rollout of the CrossLink Life Sciences, LLC ("CrossLink") partnership continues to make progress and is expected to add ~650 representatives to the promotion of ZYNRELEF by year-end. The Company anticipates that this partnership will be instrumental in successfully launching the VAN to a large base of orthopedic surgeons across the country.

https://www.biospace.com/article/releases/heron-therapeutics-announces-acceptance-of-the-prior-approval-supplement-application-for-zynrelef-vial-access-needle-and-quot-van-and-quot-/