Generic OxyContin Banned by FDA Until Reformulated to Help Abuse

Generic Oxycontin

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“Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness,” the company said in a statement.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.

Related Stories:

Hydrocodone Without Acetaminophen & 10 Times Stronger Than Vicodin Being Created
Oxycodone and Hydrocodone Prescriptions On the Rise, Addiction Epidemic
The Fight Against Prescription Drug Death Epidemic

About the Author

Jay Castillo
Environmentalist. Consumer Tech Journalist. Science Explorer. And, a dreamer. I've been contributing informative news content since 2010. Follow me on all socials!

6 Comments on "Generic OxyContin Banned by FDA Until Reformulated to Help Abuse"

  1. Purdue Pharma must be held responsible for the deaths directly or indirectly that have resulted from the use and promotion of OxyContin. Purdue should also be held responsible to pay for the treatment of those suffering from addiction to this dangerous drug. OxyContin perhaps had done more damage than illicit drugs that are smuggled from south of the boarder. President Trump will be well advised to clampdown on so called legally “Made in the USA” drugs that are killing US citizens in hundreds of thousands and turning American youth into drug addicts. Medical doctors should be prohibited from prescribing OxyContin or similar drug to new patients.

  2. All this does is raise the price for patients who actually NEED this medication. Forcing them to pay more for the name brand meds. It won’t stop abuse, and most likely will not even slow it down. Way to go FDA…Screw the patients, everyone else is….may as well follow suit.

  3. Chronic Pain | April 17, 2013 at 1:01 pm | Reply

    I have chronic pain. I must be addicted to pain. Maybe thats why I lay in bed crying. I get about 2 hours of sleep a night. I need meds. I have been taking for 8 years, and until the pain is gone, I will continue using pain killers. Sure I am addicted, but thats my problem and my choice to take them. I can stop anytime, but I wouldn’t be able to work or get out of bed for that matter. Life, liberty, and the pursuit of happiness mean nothing in this demoralized nation. Maybe I should start doing heroine? I have seen friends with similar conditions actually do that. Doctor cuts them off, can’t find pill on street so turns to another opiate. This is why you get drug problems. Once they turn to heroine its like theres no going back. IF you believe in freedom, stop wrapping yourself in the flag and trying to effen regulate everyones life! I should be able to go to the barber shop like you could 100 years ago, and get whatever I want. Tell me, if the doctors can’t “treat” my pain – and I have spent 10’s of thousands of dollars on treatments – still can’t get out of bed with out a pill – i can’t even move. Why do I have to go to a doctor every month just to get a effen refill? I mean, its a waste. I paid 104 dollars for 5 minutes and get a piece of paper saying I can get x amount. I should be able to go to store and get what I want. I know whats wrong my back hurts from my S1 all the way to my neck. ITS MY ENTIRE SPINE! NO PERSON ON THIS EARTH HAS THE RIGHT TO REGULATE FREEDOM!!!

  4. Damage from OxyContin is done, Big Pharma companies should have to pay for the ravished addicts we have in every city across our country. The FDA under a republican administration allowed this highly addictive substance on the market. MAKE THE CORPORATION PAY !!!!

    • The h&ll with that. It’s a useful drug for those in pain. Hold the abusers responsible. Accuracy note: Purdue isn’t exactly Big Pharma.

    • The political party affiliation has no impact on the FDAs decision to allow Oxy to be sold in a highly addictive and easy to abuse format. It’s just bad medicine.

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