FDA approves first generic versions of Suboxone (buprenorphine and naloxone)- Drug Information Update

The U.S. Food and Drug Administration approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.

Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema (accumulation of fluid causing swelling in lower limbs). These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

To learn more, please visit: First Generic Versions of Suboxone.