The Food and Drug Administration (FDA) announced Tuesday, April 16, 2013, that it will not approve any generic version of OxyContin until it gets made with the new formula.
The generic Oxycontin is still being made with the original formula, which the FDA believes makes the drug easier to abuse.
“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 right now.
The new formula of OxyContin was developed by Purdue Pharma LP after years of research to create a tamper-resistant version of the painkiller.
“Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness,” the company said in a statement.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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 new Oxycontin tablet is harder to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of the reformulated painkiller is expected to make it difficult to inject and to reduce abuse via snorting.
Oxycodone hydrochloride is the chemical name of the drug, which is sold under the brandname OxyContin. Fox News reported that, without competition from generics, the price of the painkiller is not likely to decrease.
Oxycontin already has a Schedule II status in controlled substances as a potentially harmful and restricted-access narcotic, based on an FDA review.
In January, a FDA advisory panel voted to move other hydrocodone-containing painkillers such as Vicodin and Percocet into the same status. Meaning, no prescription for a controlled substance in schedule II may be refilled.
Schedule II substances are typically only given once a month. Federal law does not allow refills to be given, unless the doctor thinks it’s necessary. If that’s the case, he/she can write a new 30-day prescription to the patient.
The FDA approved the original formula of OxyContin in 1995. While the painkiller was manufactured to release pain over about 12 hours, crushing the tablets defeated those extended-release properties and produced a fast, powerful high when snorted, injected or even sprinkled on food. OxyContin became known as “hillbilly heroin.”
With that type of abuse, the FDA says an increased “risk of serious adverse events, including overdose and death,” could happen.
OxyContin is one of the top selling prescription drugs within the United States, bringing in over $2.8 billion in sales just last year.
With prescription drugs being the leading source of drug abuse, having a new formula will help prevent the misuse and fight against prescription drug abuse.
FDA Bans Generic Oxycontin in Bid to Stop Abuse
The U.S. Food and Drug Administration late Tuesday banned generic versions of the narcotic OxyContin, a victory for Purdue Pharma, which produces a version that is resistant to abuse via injection and snorting.
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