FDA Approves Generic Option for Opioid Dependence

The FDA has approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

The improvement of access to prevention, treatment, and recovery services is a major focus of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, and one way in which the FDA is hoping to increase access is through the approval of generic versions of medication-assisted treatment options.

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Adverse events associated with the use of buprenorphine and naloxone include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, insomnia, and peripheral edema.

—Michael Potts

Reference:

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence [press release]. June 14, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm?utm_campaign=06142018_PR_Suboxone%20sublingual%20film&utm_medium=email&utm_source=Eloqua.