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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vanzacaftor, tezacaftor, and deutivacaftor
Trade Name: Alyftrek
Date Designated: 10/26/2020
Orphan Designation: treatment of cystic fibrosis
Orphan Designation Status: Designated/Approved
Vertex Pharmaceuticals Incorporated
50 Northern Avenue
Boston, Massachusetts 02210
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: vanzacaftor, tezacaftor, and deutivacaftor
Trade Name: Alyftrek
Marketing Approval Date: 12/20/2024
Approved Labeled Indication: treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Exclusivity End Date: TBD  
2 Generic Name: vanzacaftor, tezacaftor, and deutivacaftor
Trade Name: Alyftrek
Marketing Approval Date: 03/27/2026
Approved Labeled Indication: treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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