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.

Download the Medication-Assisted Treatment eBook

Learn more about Suboxone and other medication-assisted treatment solutions to help your loved one overcome an opioid addiction.


209 Responses

Leave your Response
    User Picture


    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.

    User Picture


    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!!!!

Leave a Comment

Please leave a comment below to contribute to the discussion. If you have a specific question, please contact a Parent Specialist, who will provide you with one-on-one help.

Your email address will not be published. Required fields are marked *