Wednesday, July 30, 2014
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FDA won't approve original generic versions of painkiller OxyContin, which are easier to abuse

The FDA late Tuesday halted plans of generic drug companies hoping to sell their versions of the opioid painkiller OxyContin starting this week.

FDA won't approve original generic versions of painkiller OxyContin, which are easier to abuse

The Food and Drug Administration late Tuesday halted plans of generic drug companies hoping to sell their versions of the opioid painkiller OxyContin starting this week.

Under pressure to help thwart deaths from opioid painkiller overdose deaths, the FDA said it had approved new labeling for the reformulated OxyContin tablets, which are harder to crush, smoke or inject.

The new label for the brand-name drug means the FDA won't approve generic versions, which are supposed to essentially copy whatever is deemed the standard of care.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

Purdue Pharma, L.P., makes OxyContin, so the move is good news for that company.

Malvern-based Endo Health Solutions is in a similar position with its opioid painkiller, Opana ER. The FDA must respond to Endo's citizens' petition for a similar decision by May.

The FDA statement is here.

 

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

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