Heron Therapeutics announces FDA acceptance of ZYNRELEF VAN supplement; PDUFA goal date September 23, 2024

HERON THERAPEUTICS, INC. /DE/

FDA acknowledged receipt of Prior Approval Supplement for ZYNRELEF Vial Access Needle (bupivacaine/meloxicam); PDUFA goal date September 23, 2024.
If approved, VAN would replace vented vial spike, reducing withdrawal time from up to 3 minutes to 20-45 seconds.
VAN expected to be available in Q4 2024 if approved; CrossLink partnership on track to add ~650 representatives by year-end.
CEO Craig Collard expressed optimism that VAN and CrossLink partnership could increase adoption among orthopedic surgeons.

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