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Bupivacaine controlled release - DURECT Corporation

Drug Profile

Bupivacaine controlled release - DURECT Corporation

Alternative Names: Bupivacaine extended release - DURECT Corporation; Optesia; POSIDUR; POSIMIR; SABER®-bupivacaine

Latest Information Update: 05 Aug 2019

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At a glance

  • Originator DURECT Corporation
  • Developer DURECT Corporation; Takeda Pharmaceuticals International GmbH
  • Class Anilides; Local anaesthetics; Non-opioid analgesics; Pipecolic acids; Piperidines; Small molecules
  • Mechanism of Action Sodium channel antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Postoperative pain

Most Recent Events

  • 01 Aug 2019 FDA assigns PDUFA action date of 27/12/2019 for bupivacaine controlled released for Postoperative pain
  • 17 Jul 2019 The US FDA accepts submission of full response to the Complete Response Letter for Postoperative pain
  • 17 Jul 2019 The US FDA has set the user fee goal date for bupivacaine controlled release as 27 December 2019
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