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SequestOx Approval Status

  • FDA approved: No
  • Brand name: SequestOx
  • Generic name: naltrexone and oxycodone hydrochloride
  • Company: Elite Pharmaceuticals, Inc.
  • Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.

In July 2016, Elite Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for SequestOx. The CRL determined that the NDA was not ready for approval in its present form.

Development Status and FDA Approval Process for SequestOx

DateArticle
Jul 15, 2016FDA Issues Complete Response Letter For SequestOx New Drug Application
Mar 17, 2016Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA
Oct 21, 2015Elite Pharmaceuticals Announces Positive Top-Line Results From a Pivotal Phase 3 Study for Abuse-Deterrent Opioid ELI-200

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