Vertex Submits Supplemental New Drug Application (sNDA) To U.S. Food And Drug Administration For KALYDECO (ivacaftor ... 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
Oct. 2, 2013 - DrugDiscoveryOnline