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.