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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217660
Company: VERTEX PHARMS INC

Products on NDA 217660

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIKAFTA (COPACKAGED)	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR	80MG, 60MG, 40MG;59.5MG	GRANULES;ORAL	Prescription	None	Yes	No
TRIKAFTA (COPACKAGED)	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR	100MG, 75MG, 50MG;75MG	GRANULES;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217660

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2023	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217660s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217660orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217660Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2025	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/20/2024	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273Orig1s013;217660Orig1s005correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212273Orig1s013;217660Orig1s005correctedltr.pdf
12/20/2024	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273Orig1s012;217660Orig1s003correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212273Orig1s012;217660Orig1s003correctedltr.pdf
08/03/2023	SUPPL-2	Labeling-Patient Package Insert, Labeling-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

Labels for NDA 217660

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273Orig1s013;217660Orig1s005correctedlbl.pdf
12/20/2024	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273Orig1s013;217660Orig1s005correctedlbl.pdf
12/20/2024	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273Orig1s012;217660Orig1s003correctedlbl.pdf
08/03/2023	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s011,217660s002lbl.pdf
08/03/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s011,217660s002lbl.pdf
04/26/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217660s000lbl.pdf

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