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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206038
Company: VERTEX PHARMS INC

Summary Review

Products on NDA 206038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORKAMBI	IVACAFTOR; LUMACAFTOR	125MG;200MG	TABLET;ORAL	Prescription	None	Yes	Yes
ORKAMBI	IVACAFTOR; LUMACAFTOR	125MG;100MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206038Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-17	Labeling-Package Insert, Labeling-Patient 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-16	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206038Orig1s016ltr.pdf
08/15/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s010Ltr.pdf
01/25/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206038Orig1s007ltr.pdf
09/06/2016	SUPPL-6	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s006ltr.pdf
09/28/2016	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s005ltr.pdf
08/05/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/06/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/18/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/18/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s001ltr.pdf

Labels for NDA 206038

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206038s017,211358s005lbl.pdf
08/03/2023	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206038s017,211358s005lbl.pdf
09/02/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf
09/02/2022	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206038s016lbl.pdf
08/15/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s010lbl.pdf
01/25/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206038s007lbl.pdf
09/28/2016	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf
05/18/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf
07/02/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf

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