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FDA Approves Generic Option for Opioid Dependence

June 15, 2018

The FDA has approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence. The generic treatment will be marketed by Mylan Technologies and Dr. Reddy's Laboratories.

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.

The film strip is used daily for the reduction of withdrawal symptoms, cravings for opioids and the high from abusing them. The treatment is placed under the tongue and dissolves. 

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.

“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," Scott Gottlieb, MD, FDA commissioner, said in a press release. "That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access."

—Michael Potts and Julie Gould

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