Heron Therapeutics Submits Prior Approval Supplement To FDA For Zynrelef VAN

(RTTNews) - Heron Therapeutics, Inc. (HRTX) announced on Wednesday that it has submitted a Prior Approval Supplement or PAS Submission to the FDA for Zynrelef also known as the 'bupivacaine and meloxicam' extended-release solution Vial Access Needle or VAN.

The company is expecting to receive the assigned action date for the FDA's review of this PAS in the next few weeks, with an estimated timeline of 4 to 6 months for an action date on this PAS.

If approved, the VAN will replace the vented vial spike previously used and could potentially reduce Zynrelef's withdrawal time to 20 to 40 seconds.

Zynrelef was first approved by the FDA in May 2021 and has since received approval for two expanded label sNDAs, one in December 2021 and the other in January 2024.