U.S. regulators approve 1st generic version of an under-the-tongue treatment for opioid addiction
U.S. regulators have approved the first generic version of an under-the-tongue film for treating opioid addiction.
The Food and Drug Administration on Thursday approved a generic version of Suboxone, a film strip that dissolves under the tongue. Used daily, it reduces withdrawal symptoms, cravings for opioids and the high from abusing them.
The medication combines buprenorphine and naloxone. It’s used along with counseling and other behavioral therapy.
The generic version will be sold by partners Mylan N.V. and Dr. Reddy’s Laboratories SA. They didn’t immediately respond to questions about when their version will be available or what it will cost.
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Brand-name Suboxone film costs about $200 a month without insurance.
The FDA said the approval was aimed at making the treatment available to more people.