Unapproved Oxycodone Drugs Ordered Off the Market by FDA

Unapproved manufacturers of the painkiller oxycodone are being targeted by the FDA and being asked to halt production and distribution. The Unapproved Drugs initiative, started in 2006, is intended to remove drugs from the market that have not gone through the appropriate measures of approval. “Federal Register” notices have been given to manufacturers of multiple unapproved drugs, some of which date back to the 1800’s. The current notice is aimed at single ingredient, instant-release drugs that contain oxycodone. Oxycodone, known on the streets as “Oxy”, has been labeled a controlled substance by the government because of the high rates of overdose 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 Lisa 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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