FDA Approves Two Generic Versions of Suboxone

The Food and Drug Administration (FDA) informed the maker of the opioid addiction treatment Suboxone that it has approved two generic versions of the drug, according to Reuters. The company, Reckitt Benckiser, had asked the agency to block the generic products because of concerns over pediatric poisonings.

Reckitt asked the FDA to refuse applications from generic drug makers unless they adopted stricter packaging standards. The FDA decided there was not enough evidence to support the need for stricter packaging, Reuters notes.

The agency said it received comments that Reckitt’s request was an anti-competitive practice, and will refer the company to the Federal Trade Commission.

The company voluntarily withdrew the sale of Suboxone tablets in the United States, and instead is selling individually sealed film strips, which melt under the tongue. Reckitt said tablets posed a risk of poisoning for children who accidentally got hold of them.

In a statement, Reckitt noted it “is disappointed with the decision but will continue to work with the FDA on safety enhancements.” The company said it will carry on with the decision to discontinue the sale of tablets of Suboxone in the United States.

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205 Responses

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    I’m tara

    April 16, 2017 at 1:03 PM

    The white generics in my
    Opinion are no different then brand .. now on the other hand the orange generics are so weak I withdrawal two AfterShip I take it be careful and be aware there is a definitive difference

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    David Wetherbee

    April 13, 2017 at 4:27 PM

    My addiction to opiates started in 1977-78. I ended up a heroin addict and then a methadone addict. I started Suboxone in 2004 and have been on it since. It gave me back the ability to be a functional member of society and it helps the pain in my back from a degenerative disc issue. I rely on insurance to pay because I would go hungry if I had to pay cash. That stuff costs little to make but the pharmacy price is unaffordable to many, even with coupons. It’s ridiculous that the price is so high. Even generic brands are overpriced, and they’re just over half the price of brand name Suboxone. Most people need it twice or three times a day, especially people with chronic pain issues. But it is an excellent detox med. and it takes away the intense fear of withdrawal which is fantastic. It’s a great medicine that probably saved my life.

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    Mark wisniewski

    March 19, 2017 at 11:16 AM

    Hi, my name is Mark, I have been on suboxone for pain, since 2004, 12 years…..I was taking oxycontin, and percocet for break through pain…I have had 9 back surgeries, and suboxone saved me…..my question to anyone is…I like the tabs, my insurance company are Jerks, express scripts, and wouldn’t let me get my script 1 day early cause my pharmacy isn’t open on sunday…but I got white pills instead of orange..is there a difference? I get different manufacturers but white taste terrible…thanks

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    February 13, 2016 at 5:12 PM

    I have been on Suboxone for pain for 10 years. Before that I was on every kind of narcotic there is and was horrible after many years of narcotics. Suboxone saved me for sure. I have been through the time when the generic tablets form was finally available to us here in US. Now I have just found out that my Insurance Company will now pay for the Brand name film strips which have no generic form because Brand name tablets are no longer available. It’s odd that my insurance Company would rather pay for Brand name over generic tablets. So far I like the film strips. The only draw back I have so far is I can’t put them in my travel pill bottle. But I can now just put them in my wallet. Pretty cool actually. It’s a little getting used to the very bitter taste of the film strips but as long as I place the film strip under tongue at the base on my left or right side, kit stays in place and I can barely taste it and they dissolve way faster than the tablets. So yayyy to the the Company who has made it possible for me to be on the Best Chronic Severe pain medication on the Market to Date.

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    Jana Logsdon

    January 15, 2016 at 3:42 PM

    I would like to say I’ve been on suboxone for years & not because I was on drugs. My Dr. Put me on it for pain, I have fibromyalgia and I’ve been on everything else you can think of 80mg OxyContin 3 times a day + all kinds of other medican it was the worst time of my life. All that medican did was make me hurt worse and drag me down. Suboxone has been a miracle for me. It gave me my life back. My point is that it is ridicules how expensive suboxone is. I will probably never be able to get off of it. Y’all need to lower the price on suboxone. I’m not sure how long I will be able to afford it. PLEASE HELP US.

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