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Vertex Submits Supplemental New Drug Application (sNDA) To U.S. Food And Drug Administration For KALYDECO (ivacaftor) Monotherapy For People With Non-G551D Gating Mutations
2013-10-02 05:50:27| drugdiscoveryonline News Articles
Vertex Pharmaceuticals Incorporated recently announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of KALYDECOTM (ivacaftor) monotherapy for people with cystic fibrosis (CF) ages 6 and older who have at least one non-G551D gating mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
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Category:Biotechnology and Pharmaceuticals
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