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Drug Names(s): Zolpidem controlled-release, FK199B modified-release
Description: Ambien CR is a controlled release version of Ambien (zolpidem). Zolpidem is a short-acting hypnotic agent with a chemical structure unrelated to benzodiazepines. It binds, however, to the benzodiazepine receptor, which is the major modulatory site of the GABA-A receptor complex located on its alpha subunit. Zolpidem potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. Subunit modulation of the GABA-A complex is thought to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties.
Deal Structure: In November 2007, sanofi-aventis and Astellas Pharma announced today that they have agreed to restructure their joint venture activities in Japan (FSA). Established in 1982, FSA is a joint venture company 51% owned by sanofi-aventis and 49% by Astellas. FSA owns the rights to manufacture and sell certain products originating from sanofi-aventis such as Ambien (Myslee in Japan). In the restructuring, sanofi-aventis K.K., the Japanese subsidiary of sanofi-aventis, shall obtain certain rights to Myslee. Myslee will continue to be co-promoted by sanofi-aventis K.K. and Astellas and distributed by Astellas.
Partners: Astellas Pharma, Inc.
Ambien CR News
Pink Sheet Ambien CR Paragraph IV Certification Filed
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