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Pivotal bioequivalence trial of ELI 200 vs branded formulation.

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Trial Profile

Pivotal bioequivalence trial of ELI 200 vs branded formulation.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Jul 2016

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At a glance

  • Drugs Oxycodone/naltrexone (Primary) ; Opioid analgesics
  • Indications Pain
  • Focus Pharmacokinetics; Registrational
  • Sponsors Elite Pharmaceuticals

Most Recent Events

  • 15 Jul 2016 According to Elite Pharmaceuticals media release, the U.S. Food and Drug Administration (the "FDA") has issued a Complete Response Letter (the "CRL") regarding the New Drug Application (the "NDA") for SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride). The CRL determined that the NDA was not ready for approval in its present form.
  • 09 May 2016 According to an Elite Pharmaceuticals media release, the New Drug Application (NDA) for ELI-200 (SequestOX) has been accepted and granted priority review by the FDA with target action date under the Prescription Drug User Fee Act (PDUFA) of July 14, 2016.
  • 09 Feb 2016 Elite Pharmaceuticals has submitted a 505(b)(2) NDA to the US FDA, according to a company media release.

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