FDA Approves Generic Suboxone Sublingual Film for Opioid Dependence Treatment

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The approval is intended to increase patient access to treatment for opioid addiction.

On June 14, 2018, FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for treating opioid dependence. The approval was granted to Mylan Technologies and Dr. Reddy's Laboratories, who will market buprenorphine and naloxone sublingual film in multiple strengths.

“[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,” said FDA Commissioner Scott Gottlieb, MD, in a press release issued by the agency.

“[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 one 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,” Gottlieb added.

Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.

At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of OUD cut their risk of death from all causes in half.


FDA’s ongoing work to reduce the scope of the opioid crisis includes improving access to prevention, treatment, and recovery services, including the full range of MAT. This is also the goal of the United States Department of Health and Human Services’ five-point strategy to combat the opioid crisis.

FDA will focus on decreasing exposure to opioids and preventing new addiction by taking new steps to encourage more appropriate prescribing. The agency will also support treatment of those with OUD and promote the development of improved and lower-cost forms of MAT. It will foster the development of novel pain treatment therapies that may not be as addictive as opioids and opioids more resistant to abuse and misuse, as well as take action against those who contribute to the illegal importation and sale of opioid products.

The agency intends to also continue evaluating how drugs currently on the market are used, in both medical and illicit settings, and will take regulatory action where needed.

Source: FDA