FDA Approves First Generic of Drug Used to Treat Opioid Dependence – APhA submits compounding comments to FDA. – (866) 348-2889.
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.”