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US FDA Grants Approval For Reckitt Benckiser's Suboxone Sublingual Film

Reckitt Benckiser Pharmaceuticals Ltd (RB.L) Monday announced that the U.S. Food and Drug Administration, or the FDA, has granted approval for 4 mg dose and 12 mg dose of Suboxone sublingual film.

Suboxone sublingual film is indicated for maintenance treatment of opioid dependence, also known as prescription opioid painkiller and heroin addiction, a growing epidemic in the United States.

Opioid dependence is a chronic and progressive medical condition caused in part by the changes in the chemistry of the brain that can result from regular opioid drug use. Dependence on opioids has been defined as a chronic (long-term) brain disease by the World Health Organization and the National Institute on Drug Abuse. Once opioid dependence develops, it is a chronic condition that left untreated can be fatal.

The pharmaceutical company further added that it has developed the 4 mg and 12 mg strengths in an ongoing effort to help mitigate the risk of unintentional multi-dose pediatric exposure, which is a major public health concern associated with medications.

by RTTNews Staff Writer

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