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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211358
Company: VERTEX PHARMS INC

Products on NDA 211358

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORKAMBI	IVACAFTOR; LUMACAFTOR	125MG/PACKET;100MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No
ORKAMBI	IVACAFTOR; LUMACAFTOR	188MG/PACKET;150MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	Yes
ORKAMBI	IVACAFTOR; LUMACAFTOR	94MG/PACKET;75MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211358

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2018	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211358Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211358Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2026	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211358s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/206038Orig1s020;211358Orig1s008ltr.pdf
09/25/2025	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206038s019,211358s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206038Orig1s019,211358Orig1s007ltr.pdf
12/13/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206038s018,211358s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206038Orig1s018,211358Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206038Orig1s018,211358Orig1s006ltr.pdf
08/03/2023	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206038s017,211358s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206038Orig1s017;211358Orig1s005ltr.pdf
09/02/2022	SUPPL-4	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211358Orig1s004ltr.pdf

Labels for NDA 211358

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2026	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211358s008lbl.pdf
09/25/2025	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206038s019,211358s007lbl.pdf
09/25/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206038s019,211358s007lbl.pdf
12/13/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206038s018,211358s006lbl.pdf
08/03/2023	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206038s017,211358s005lbl.pdf
08/03/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206038s017,211358s005lbl.pdf
09/02/2022	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf
08/07/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf

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