Heron Therapeutics, Inc. (HRTX) announced on Wednesday that it has submitted a Prior Approval Supplement (PAS) to the FDA for Zynrelef, known as the 'bupivacaine and meloxicam' extended-release solution Vial Access Needle (VAN).
The company anticipates receiving the assigned action date for the FDA's review of this PAS within the next few weeks, estimating a timeline of 4 to 6 months for an action date.
If approved, the VAN will replace the previously used vented vial spike and could potentially reduce Zynrelef's withdrawal time to 20-40 seconds.
Zynrelef was initially approved by the FDA in May 2021. Since then, it has received approval for two expanded label sNDAs, one in December 2021, and another in January 2024.
