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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212273
Company: VERTEX PHARMS INC

Products on NDA 212273

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212273

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 (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s011,217660s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212273Orig1s011;217660Orig1s002ltr.pdf
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

Labels for NDA 212273

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s011,217660s002lbl.pdf
08/03/2023	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s011,217660s002lbl.pdf
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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