Medication Guide App

FDA Sends GSK Letter over Arzerra Journal Ad

ROCKVILLE, MD., April 19, 2010--The FDA has posted on its website a letter it sent to GlaxoSmithKline after the angency reviewed a journal advertisement for Arzerra Injection. The FDA states in the letter, "The ad is false or misleading because it omits important information about the drug’s safety and effectiveness."  Arzerra (ofatumumab) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.

 

 

 www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM208798.pdf

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM208799.pdf

Posted: April 2010


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