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FDA Approves Cystic Fibrosis Drug

01/31/2012

The US Food and Drug Administration (FDA) announced today the approval of Kalydeco (ivacaftor), a drug manufactured by Vertex Pharmaceuticals, Inc to treat cystic fibrosis. The drug is intended for patients 6 years of age or older who have the G551 mutation. The agency reviewed and approved the drug in approximately 3 months under its priority review program and ahead of the April 18 goal date. Ivacaftor is considered an orphan drug because it is intended for a disease that affects

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FDA Approves Cystic Fibrosis Drug

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