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.
We are grateful to Reckitt for developing Suboxone and for their concerns about safety, but now it’s time to make this wonderful product more available to fight the horrible disease of addiction.
The FDA made the correct decision! This medication, along with methadone will now be much more accessible and that will safe more lives than any safety concern put at risk!
hi plz tell me are the side effects to the generic well put it this way i feel they do not last as long and become nausea , i feel the generic is to generic i was done to one sub a day now i am back up to 2
Hooray! Finally, finally, buprenorphine will be available to the people who need it most. I’ve prescribed this drug in office-based treatment since it came out in 2002. Initially, Suboxone was a badly-needed option for the cohort of opiate addicts who would not/could not go to methadone clinics — higher-functioning addicts in positions of responsibility, who previously had no options for treatment. Now we’ve seen that even more disorganized, sicker addicts can safely manage buprenorphine in office-based treatment, and it’s way past time for the treatment to be financially available to this cohort as well.
I am now practicing in New Zealand, where suboxone just become available 7 months ago. It’s very interesting to watch the treating community go through the same process we all did in America in 2002, learning to use and trust the drug.
I applaud Reckitt-Benckiser for making this treatment available in the first place, but I have long deplored R-B’s self-serving hammerlock on the drug. Surely they’ve made enough profit already… now it’s time to make it available to all who need it.
How much profit is enough? Just a little bit more….always!
I have been on suboxone for a wile and now I finally feel like I can stay clean in the long term future. I got addicted to pain medication because since I didn’t have insurance the doctors would not give me the treatment I needed and instead they gave me hundreds of pain pills a month to mask the problem so they didn’t have to do the surgeries I needed. And I did what they told me to do, take 1-2 every 4-6 hours for the pain, and for years probably 12 yrs I did that because I trusted my doctor. My attitude was he is the trained professional and he WILL NOT prescribe me something if it will hurt me, he knows what he is doing after all doctors take an oath to do no harm and not to cause more harm. For years I was fine, it wasn’t until someone came in and stole my pain pills that I started to think something was wrong with me. I got so sick and later found out it was not the flu, I had no idea what withdrawal was as far as I was concerned withdrawal involved my checking account, ya know withdrawing money. I was completely uneducated. In the end I ended up in treatment and with some legal issues all because I had no idea about the worst side effect of the pain pills, addiction. I believe suboxone is why I am still here. Suboxone and with outpatient treatment are what has saved me and allow me to stay clean and sober. I don’t know how long I will have to be on it but right now it has been 15 months. I will start the generic tomorrow because my insurance would rather pay for generic because it is cheaper than name brand. I know a lot of people that will now be able to get this medication and get better which is awesome. Now if they could increase the number of patients doctors are allowed to Prescribe suboxone to then they would be able to help a lot more people that really want and need the help.
I would like to know the difference in the price of the suboxone gerenic (strips?) and the regular subozone where u all are cause where i live in Miss. the price is not much different.
the new generic suboxones don’t work as well they give me a bad migrane and don’t help with my pain I really wish my insurance would cover my old orange ones new ones are white