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FDA Blocks Generic Version of OxyContin

Update Date: Apr 17, 2013 09:48 AM EDT
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Prescription drugs are one of the leading sources of drug abuse, which is why recent regulations have looked into ways of preventing people from misusing these drugs. The Food and Drug Administration (FDA) announced Tuesday evening, April 16, 2013, that it will not approve the generic version of OxyContin, which is a painkiller prescribed for moderate to severe pain. The FDA stated that the generic version of Oxycontin is still being made with the original formula, which the agency believes makes the drug easier to abuse, and until the generic versions are made with the new formulation changes, it will not be approved.

This new regulation will affect the profits of several generic manufacturers. OxyContin is one of the top selling prescription drugs within the United States, bringing in over $2.8 billion in sales just last year. The newer formulation of OxyContin was developed by Purdue Pharma LP after years of intensive research into creating a tamper-resistant version of the painkiller. The company had a patent on the original OxyContin, which expired this past Tuesday and due to the new regulations set by the FDA, generic drug manufacturers cannot exploit the patented formula since the original formula will no longer be accepted. Generic drug manufacturers must now design their own versions of OxyContin that would not be easily abused.

OxyContin has a lasting effect for about 12 hours, making it an effective drug in dulling pain. However, drug abusers discovered that if they snorted the pill or injected it after crushing them into a powder like substance, they could achieve a high experience similar to heroin. After more and more people abused this painkiller, Purdue Pharma LP pled guilty in 2007 for failing to warn the public about the safety and addictiveness of the drug. The company was required to pay $634 million. The newer version of the drug will have new labels indicating the possible side effects and consequences of taking OxyContin.

"While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin," The FDA deputy director, Douglas Throckmorton stated.

These new regulations will hopefully help with the fight against prescription drug abuse.

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