Kalydeco Approval History beta

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.

FDA Approval History for Kalydeco

DateArticle
Jan 31, 2012Approval FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
Dec 15, 2011FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
Oct 26, 2011Vertex Submits Application for Priority Review and Approval of Kalydeco (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis

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