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FDA clears the first generic versions of Suboxone Sublingual Film

The United States Food and Drug Administration (FDA) approved the first generic versions of sublingual Suboxone (buprenorphine and naloxone) for the treatment of opioid dependence, which may increase access to treatment, the agency said.

Mylan Technologies Inc and Dr. Reddy & # 39; s Laboratories SA received approval to commercialize the sublingual film of buprenorphine and naloxone in multiple strengths.

"The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and make sure these drugs are accessible to patients who need them, including promoting the development of better medications and also facilitate the entry into the market of generic versions of approved drugs to help ensure wider access, "said FDA Commissioner Scott Gottlieb. Press release.

The sublingual film of buprenorphine and naloxone should be used as part of drug-assisted treatment (MAT), which combines FDA-approved medications (curre nly with methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies, for patients with opioid use disorder (OUD), the FDA reports.

Adverse events commonly observed with buprenorphine and the sublingual film of naloxone are oral hypoaesthesia, glossodynia, oral mucosa erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema . These products can only be prescribed by prescribers certified by the Drug Addiction Treatment Law.

"Improving access to prevention, treatment and recovery services, including the full range of MAT, is an ongoing focus of the FDA's work to reduce the scope of the opioid crisis and a part of the strategy of five points from the US Department of Health and Human Services to combat the opioid crisis.

The FDA is also focusing its efforts on decreasing opiate exposure and preventing new addiction by encouraging a more appropriate prescription; supporting the treatment of those with OUD and promoting the development of improved and less expensive forms of TMA, encouraging the development of novel pain therapies that may not be as addictive as opiates and opiates that are more resistant to abuse and misuse; and take action against those who contribute to the illegal importation and sale of opiate products.

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