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BioWorld - Monday, April 20, 2026
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Home » Third time’s the charm: Heron wins FDA nod for non-opioid pain drug
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Third time’s the charm: Heron wins FDA nod for non-opioid pain drug

May 13, 2021
By Jennifer Boggs and Lee Landenberger
It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
BioWorld Regulatory Neurology/psychiatric FDA

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