Reckitt Subutex Combo NDA Nears Filing; Legislation Could Widen Availability
Executive Summary
Reckitt & Coleman is expected to submit an NDA for its combination buprenorphine/naloxone anti-addiction drug before the end of April.
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Addiction treatment legislation
House Commerce Committee Chairman Bliley (R-Va.) introduces "The Drug Addiction Treatment Act" July 30. The bill, a companion piece to Senate legislation (S 324) introduced in January by Sens. Hatch (R-Utah) and Levin (D-Mich.), would allow Schedule IV and V controlled substances for the treatment of addiction to be administered in a physician's office, allowing for wider distribution and application of drugs like Reckitt & Coleman's buprenorphine, which is pending approval at FDA (1"The Pink Sheet" March 15, p. 19)
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011