Public health company The US Food and Drug Administration (FDA) stated on Thursday that it has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.
Mylan Technologies Inc and Dr Reddy's Laboratories SA received the US FDA's approval to market buprenorphine and naloxone sublingual film in multiple strengths. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
The US FDA added the medication-assisted treatment (MAT) is a comprehensive approach that combines USFDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD).
At proper doses, buprenorphine decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of OUD cut their risk of death from all causes in half, said the US FDA.
Additionally, the US FDA will continue to evaluate how drugs currently on the market are used, in both medical and illicit settings and take regulatory action where needed.
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