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Reckitt Benckiser receives FDA approval for Suboxone tablets

US Food and Drug Administration (FDA) has approved Reckitt Benckiser Pharmaceuticals's Suboxone (buprenorphine and naloxone) sublingual film 4 mg and 12 mg doses.

Suboxone is an office-based treatment used to treat opioid dependence, which is also known as prescription opioid painkiller and heroin addiction.

Reckitt Benckiser Pharmaceuticals North America president Richard Simkin said Opioid dependence affects millions of Americans from all walks of life and socioeconomic levels with the number growing each year.

"As the market leader and committed partner of care, we developed Suboxone® sublingual film and the portfolio of dosage strengths to respond to critical public health issues: helping fulfill treatment needs with a product that is both effective and individualized, and reducing the risk of pediatric exposure," Simkin added.

The new 4 mg and 12 mg Suboxone dosage strengths will be available later in the year, according to Reckitt Benckiser.