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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211 Responses

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    James M

    August 18, 2019 at 2:59 PM

    I have been on Suboxone for approx. 10 years or a little longer, IT WORKS, I don’t care what anyone says, I have been working on taking less and have been able to reschedule my dr appts every month for 2 weeks later, still have a couple left at my appt, Getting clean is a struggle, but you can do it, if I can, anyone that wants to can, I started out prescribed two 8mg/2mg strips a day, Now I split them up into pieces and average 1 to 1 1/2 daily, but I just realized they make a lower dosage as well, so I may be switching, not sure yet, opiates and drugs have ruined my life, I am struggling to even live now at the age of 47, Convicted felon, no job, no license, but I consider myself lucky because I was able to keep my family intact, went through hell, but still intact. my family sticks by me, but this is no life, you don’t want to get so far gone, to where you can’t recover in life, if your young, there’s no better time than right now to start getting your life back on track, good luck and be strong, you can do it, I have faith in you

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      Jullian Blank

      September 9, 2019 at 2:17 PM

      I also…have been on Suboxone for 10+ years. My monthly 30 films of 8/2 usually last 6 to 7 weeks. I spent years hooked on pills after a plane crash. Suboxone saved my life. But I do remember that first initial doctor visit when they handed me the script for the Suboxone instead of pills, the fear I felt was paralyzing. That day is why I can write to you now. I hope others can do it too.

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    January 13, 2019 at 9:17 PM

    My hometown of Georgia has recently added Suboxone at the Methadone clinics. The cost is 12.00 per day, which is the same for Methadone. A lot of patients have switched from Methadone to Suboxone. I am one of the patients. Suboxone works better for me. They don’t have the blood pressure spike, no nodding, no weight or water gain and I do not have any cravings from day one. It seems that Suboxone is more acceptable in the work force. If you don’t have insurance, they are very expensive. I’m totally happy I switched. Good luck homies. I know what you have went through, its rough, but you can do it. God Bless.

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    December 22, 2018 at 10:07 AM

    I am a chef at a great restaurant. I got the job while I was hooked to herion. I started going through withdrawals and missing work. When I said enough and went for an appointment. I was prescribed 60 8mgs sub films a month. Upon picking my script up to pay for it the nice lady said 540 dollars for one month. Plus the fee for my doc. So I’m spending almost as much on my script as I was herion a month . It seems to me that the drug company’s don’t give a flying flip about helping people get off herion but only how much they can charge for it. Yes I understand it’s a business but part of it has to be about helping and not just profits. Please make a affordable Suboxone before I relapse and possible death. Wtf!!!!

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