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FDA Approval for TRIKAFTA (COPACKAGED) issued to VERTEX PHARMS INC

$VRTX
Biotechnology: Pharmaceutical Preparations
Health Care
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New Drug Application (NDA): 212273
Company: VERTEX PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 100MG,75MG,50MG; 150MG TABLET;ORAL Prescription None Yes Yes
TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 50MG,37.5MG,25MG; 75MG TABLET;ORAL Prescription None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/2019 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212273Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/03/2023 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
04/26/2023 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212273Orig1s009ltr.pdf
10/04/2021 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212273Orig1s008ltr.pdf
06/08/2021 SUPPL-4 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212273Orig1s004ltr.pdf
12/21/2020 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212273Orig1s002ltr.pdf
11/18/2020 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212273Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/26/2023 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf
04/26/2023 SUPPL-9 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf
10/04/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s008lbl.pdf
06/08/2021 SUPPL-4 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf
12/21/2020 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s002lbl.pdf
11/18/2020 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s001lbl.pdf
10/21/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf
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