FDA cracks down on unapproved painkillers in U.S.
Published Thursday, July 5, 2012 2:43PM EDT
WASHINGTON -- The Food and Drug Administration says it will begin cracking down on companies that market versions of the painkiller oxycodone which have not undergone federal review.
Oxycodone is a powerful pain reliever with the potential for addiction, abuse and death, when used inappropriately. The drug is marketed legally by companies like Purdue Pharma, which sells the time-release pill OxyContin. FDA reviews these drugs to make sure they are safe and effective.
However, other companies have marketed similar pills for years without FDA clearance.
In a federal register notice, the FDA said companies marketing unapproved versions of oxycodone have 45 days to cease manufacturing them. Companies that don't comply will be subject to product seizure and court proceedings.
Oxycodone and other opioid painkillers are among the most widely-abused drugs in the U.S.