Kalydeco Approval History

• FDA approved: Yes (First approved January 31st, 2012)
• Brand name: Kalydeco
• Generic name: ivacaftor
• Company: Abbott Laboratories
• Treatment for: Cystic Fibrosis

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

Date	Article
Jan 31, 2012	FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
Dec 15, 2011	FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
Oct 26, 2011	Vertex 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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Kalydeco (ivacaftor) Consumer Information

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