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Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Response to Citizen's Petition
Date:2/25/2013

anufacturers' proposed safety programs have not been provided.

RBP is a pioneer in the development of innovative prescription treatments for the chronic disease of addiction and introduced SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) in 2010 as a next generation product with enhanced features, including child-resistant, unit-dose packaging, in response to patient and provider feedback and reports of misuse, abuse, diversion and pediatric exposure associated with SUBOXONE Tablets.  RBP remains confident in the value and benefits of SUBOXONE Film as the product offers a significant advancement in formulation and product technology.

About SUBOXONE Film
Since the U.S. launch of SUBOXONE (buprenorphine and naloxone) in 2003, it is estimated that over three million Americans with opioid dependence have been treated with the active ingredients contained in SUBOXONE Film – buprenorphine and naloxone.

SUBOXONE Film is an office-based treatment that allows patients to be discreetly treated for opioid dependence in the privacy of a physician's office. Because SUBOXONE Film is approved for at-home use, people living with opioid dependence can continue their daily lives while under a physician's care similar to other chronic diseases, such as diabetes, asthma or hypertension.  Treatment with SUBOXONE Film is best delivered in conjunction with counseling and psychosocial support. 

SUBOXONE Film was initially approved by the U.S. FDA on August 30, 2010, and combines buprenorphine and naloxone in a 4:1 ratio.  SUBOXONE Film comes in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg dosage formulations, all of which are currently available in pharmacies. 

SUBOXONE Film's main active ingredient is buprenorphine, a partial opioid agonist that strongly binds to the opioid receptors in the brain and dose-dependently blocks other opioids from attaching.  Buprenorphine helps reduce opioid use and
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SOURCE Reckitt Benckiser Pharmaceuticals Inc.
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