First Generic Versions of Suboxone Get FDA Approval for Opioid Dependence
These products may only be prescribed by DATA-certified clinicians.
The first generic versions of Suboxone (buprenorphine and naloxone sublingual film) have been approved by the Food and Drug Administration (FDA) for the treatment of opioid dependence as part of a complete treatment plan that includes counseling and psychosocial support.
The treatment combines buprenorphine, a partial-opioid agonist, with naloxone, an opioid antagonist. The approval is part of the FDA's ongoing effort to reduce the opioid epidemic. In a press statement, FDA Commissioner Scott Gottlieb, MD said “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."
Both Mylan and Dr. Reddy's Laboratories have received approval to market the generic versions in multiple strengths. Use of this product is limited under the Drug Addiction Treatment Act (DATA); only DATA-certified healthcare professionals can prescribe the drug.
Dr. Reddy's Laboratories has already announced the launch of their Buprenorphine and Naloxone Sublingual Film in 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg strengths. The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) program.