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Remoxy Approval Status

  • FDA approved: No
  • Brand name: Remoxy
  • Generic name: oxycodone
  • Company: Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
  • Treatment for: Pain

Remoxy (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.

Development Status and FDA Approval Process for Remoxy

Apr 12, 2016FDA Accepts Remoxy NDA for Review
Mar 29, 2016Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration
Oct 27, 2014Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII
Jun 24, 2011FDA Complete Response Letter Received for Remoxy
Jan 27, 2011Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011
Dec 27, 2010King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy
Dec 11, 2008Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy
Jun 10, 2008Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy

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