FDA orders unapproved oxycodone drugs off market

SILVER SPRING, Md. — The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

The FDA said it issued the Federal Register notice as part of the Unapproved Drugs Initiative, a program it started in June 2006 to remove drugs from the market that have largely avoided regulatory scrutiny generally because their availability predates the agency's current regulatory standards; some drugs removed from the market under the initiative in the past date back to the 1800s. All the drugs in the current notice are single-ingredient, immediate-release products with oxycodone, an opioid analgesic that the government considers a controlled substance because it has been linked to overdoses and abuse.

"It's a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective and of poor quality," FDA Center for Drug Evaluation and Research Office of Compliance acting director Ilisa Bernstein said. "Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply."


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