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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 is long-acting oral oxycodone forumulated to resist common methods of prescription drug misuse and abuse. Remoxy is in development for the treatment of moderate to severe chronic pain.

FDA Approval Status for Remoxy

DateArticle
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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