FDA prompts removal of unapproved oxycodone products

As part of the FDA's Unapproved Drugs Initiative, the Agency issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The Unapproved Drugs Initiative, which began in June 2006, is the Agency's risk-based enforcement approach to efficiently bring all unapproved new drugs into the approval process.

The FDA action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. The FDA has not evaluated these products for safety, effectiveness, manufacturing quality or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States.

Products that are subject to this issuance are those that were:

  • Introduced onto the market before September 19, 2011
  • Listed in the FDA's Drug Registration and Listing System before July 6, 2012
  • Being commercially used or sold before July 6, 2012.

Oxycodone is a schedule II opioid analgesic indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

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