LOUISVILLE -- The U.S. Food and Drug Administration has blocked generic drug manufacturers from producing versions of the old crushable.
"The FDA will not approve any generics to the original formulation of OxyContin," said FDA spokeswoman Morgan Liscinsky, adding that there are no FDA-approved generics of OxyContin on the market now.
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LOUISVILLE — The U.S. Food and Drug Administration has blocked generic drug manufacturers from producing versions of the old crushable form of OxyContin that was widely abused across the nation — a decision applauded by politicians and law enforcement.
But in January, David Gaugh, senior vice president for science and regulation at the association, told The (Louisville, Ky.) Courier-Journal that the vast majority of painkillers are taken by legitimate patients, and "we see a very strong need for these products that are not tamper-resistant." Generics typically cost 60% to 80% less than brand-name drugs, Gaugh said at the time, and if generics were not allowed, he said legitimate patients would be forced to pay more.
Manufacturer Purdue Pharma 's patent on the original drug was set to expire Tuesday, and activists, lawmakers and doctors worried that cheaper, easily crushable generic versions would flood Kentucky and exacerbate the state's already devastating drug-abuse problem.
Kentucky's prescription-pill abuse epidemic is among the nation's worst, killing nearly 1,000 residents annually and destroying thousands more lives.
LOUISVILLE -- The U.S.
FDA's approval of two generic oxycodone hydrochloride products should make this safe and effective medicine available at a lower cost to.
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Earlier this month, the Office of National Drug Control Policy, the DEA, and FDA announced a coordinated strategy to confront the illegal diversion and abuse of prescription drugs. This coordinated strategy includes:
When used correctly, opioids play a very important role in the management of pain. FDA's job is to maximize the potential benefits that patients receive from these drugs, while, at the same time, minimizing the risks associated with these products.
For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic version of the highly addictive OxyContin.
"I think all of the participants in this part of the business, the onus is on us to to provide patients with drugs with the maximum safety to avoid abuse, while insuring that the 10% to 12% of Americans who suffer from chronic pain have access to the pain medications they need.". Stock said draft guidance the FDA put out in January also shows the way forward for this thorny issue.
This is a landmark decision by the FDA." He said it was not only important that the FDA was keeping generics of the original formulation off the market but also allowing those companies with tamper protected formulations to make a "label claim.".
The generic form of the brand name OxyContin is called oxycodone hydrochloride extended-release. Oxycodone is the active ingredient in OxyContin.
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Oxycodone is the active ingredient in OxyContin. The generic form of the brand name OxyContin is called oxycodone hydrochloride extended-release. Your doctor may choose to prescribe the generic as an alternative to OxyContin because they are essentially the same medication. Discover Find a Doctor Stay Connected.
Although there's no generic equivalent for OxyContin, the Avalere analysis found that generic oxycodone, which contains the same active.
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