Heron submits PAS to FDA for ZYNRELEF Vial Access Needle to simplify preparation

HERON THERAPEUTICS, INC. /DE/

PAS seeks FDA approval to replace current vented vial spike with new Vial Access Needle (VAN).
VAN reduces product withdrawal time from up to 3 minutes to 20-45 seconds, simplifying aseptic preparation.
Heron expects FDA review action date within 4-6 months; decision pending.
ZYNRELEF is already approved for postoperative pain; VAN addresses healthcare provider feedback.

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