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The company has requested priority review of its NDA application and, if granted, Clolar could be approved for this indication in the first half of 2009.
Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients aged one to 21 years old who have received at least two prior treatments and it is now a standard of care in this setting, according to the company. A In addition,AClolar has Orphan Drug designation for adult and pediatric ALL, and seven years of market exclusivity in the United States for relapsed/refractory pediatric ALL. The FDA also granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.
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