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Kalydeco Approval History

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Development History and FDA Approval Process for Kalydeco

Aug  1, 2017Approval FDA Approves Kalydeco (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
May 17, 2017Approval FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis
Mar 18, 2015Approval FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
Dec 29, 2014Approval FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
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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