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FDA Approves First Generic Under-the-Tongue Suboxone

FRIDAY, June 15, 2018 -- The first generic version of an under-the-tongue film to treat opioid addiction has been approved by the U.S. Food and Drug Administration.

The generic version of Suboxone (buprenorphine and naloxone) film from Mylan Technologies Inc. and Dr. Reddy's Laboratories SA will be available in different strengths.

The brand name and generic films should be used as part of an overall treatment plan that includes counseling and psychosocial support, and may only be prescribed by Drug Addiction Treatment Act-certified prescribers, the FDA said.

Common side effects of these films include numbness, burning and inflammation in the mouth, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

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Posted: June 2018