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Thursday, 26 April 2012
Notice of Decision for ARZERRA™
Health Canada has issued a Notice of Compliance with conditions under the Notice of Compliance with Conditions (NOC/c) Policy to GlaxoSmithKline Inc., for the drug product, Arzerra™ on the basis of the promising nature of the clinical evidence, and the need for confirmatory studies to verify the clinical benefit. Arzerra™ is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. Read the notice of decision here.