Medication Guide App

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.

FDA Approval Status for Remoxy

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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