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U.S. Department of Health and Human Services


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Kalydeco (Ivacaftor)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View



Clinical Trials Experience
  • Overall, the most common adverse reactions in 221353 patients with CF who had either a G551D mutation or were homozygous for the F508del mutation in the CFTR and treated with Kalydeco