FDA Approves First Generic of Drug Used to Treat Opioid Dependence


Agency officials have given the green light to versions of buprenorphine and naloxone (Suboxone, Mylan Technologies Inc and Dr. Reddy's Laboratories SA) sublingual film.

FDA officials have approved the first generic versions of buprenorphine and naloxone (Suboxone, Mylan Technologies Inc and Dr. Reddy's Laboratories SA) sublingual film to treat opioid dependence.

“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction. Patients addicted to opioids who are eventually treated for that addiction and successfully transition onto medicines like buprenorphine aren’t swapping 1 addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”

Adverse effects commonly observed with the buprenorphine and naloxone sublingual film are accumulation of fluid causing swelling in lower limbs, burning mouth, constipation, excessive sweating, headache, inflammation of oral mucous membrane, insomnia, nausea, oral numbness, pain, signs and symptoms of withdrawal, and vomiting. Buprenorphine and naloxone sublingual film may only be prescribed by Drug Addiction Treatment Act-certified prescribers, and should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Improving access to prevention, treatment, and recovery services, including the full range of Medication-assisted Treatment (MAT), is a focus of the FDA’s continuing work to reduce the scope of the opioid crisis and 1 part of the U.S. Department of Health and Human Services’ 5-Point Strategy to Combat the Opioid Crisis. One of the ways that the FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. In an effort to promote competition that would help reduce drug prices and to improve access to safe and effective generic medicines for individuals in the United States, the agency is taking a number of new steps as part of its Drug Competition Action Plan. This includes working to improve the efficiency of the generic drug approval process and address barriers to generic drug development.

Generic drugs approved by the FDA have, among other things, the same quality as brand-name drugs, according to the agency. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.


FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence [news release]. Silver Spring, MD: June 14, 2018; FDA website. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm. Accessed June 14, 2018.

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