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Bupivacaine/meloxicam - Heron Therapeutics

Drug Profile

Bupivacaine/meloxicam - Heron Therapeutics

Alternative Names: Bupivacaine/meloxicam extended release; HTX-002/HTX-009; HTX-009/HTX-002; HTX-011; HTX-011A; HTX-011B; Meloxicam/bupivacaine; Meloxicam/bupivacaine extended release; ZYNRELEF

Latest Information Update: 10 Jul 2024

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At a glance

  • Originator Heron Therapeutics
  • Class 2 ring heterocyclic compounds; Amides; Anilides; Antipyretics; Local anaesthetics; Non-opioid analgesics; Nonsteroidal anti-inflammatories; Pipecolic acids; Piperidines; Small molecules; Thiazines; Thiazoles
  • Mechanism of Action Cyclo-oxygenase 2 inhibitors; Sodium channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Postoperative pain

Most Recent Events

  • 10 Jul 2024 FDA assigns PDUFA action date of (23/09/2024) for Bupivacaine/Meloxicam for Postoperative pain extended-release solution VAN
  • 02 Jul 2024 USFDA acknowledged the receipt of the Company's Prior Approval Supplement ("PAS") application of Bupivacaine/meloxicam for Postoperative pain (Controlled-release) in USA
  • 29 May 2024 Heron Therapeutics announced the Prior Approval Supplement ("PAS") submission to the US FDA for ZYNRELEF®
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