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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207925
Company: VERTEX PHARMS INC

Summary Review

Products on NDA 207925

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KALYDECO	IVACAFTOR	50MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No
KALYDECO	IVACAFTOR	75MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	Yes
KALYDECO	IVACAFTOR	25MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No
KALYDECO	IVACAFTOR	5.8MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No
KALYDECO	IVACAFTOR	13.4MG/PACKET	GRANULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207925

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2015	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207925Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000SumR.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	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s040,207925s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203188Orig1s040;207925Orig1s017ltr.pdf
05/03/2023	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207925Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207925Orig1s016ltr.pdf
12/21/2020	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s034,207925s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203188Orig1s034, 207925Orig1s013ltr.pdf
09/24/2020	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s033,207925s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207925Orig1s011;203188Orig1s033ltr.pdf
04/29/2019	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203188s029,207925s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203188Orig1s029, 20795Orig1s008ltr.pdf
08/15/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203188Orig1s028,207925Orig1s007ltr.pdf
07/31/2017	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s026,207925Orig1s005ltr.pdf
02/08/2017	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s022,207925Orig1s003ltr.pdf
06/08/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/17/2017	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207925s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf

Labels for NDA 207925

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/2023/203188s040,207925s017lbl.pdf
05/03/2023	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207925Orig1s016lbl.pdf
12/21/2020	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s034,207925s013lbl.pdf
09/24/2020	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s033,207925s011lbl.pdf
04/29/2019	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203188s029,207925s008lbl.pdf
08/15/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf
07/31/2017	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf
05/17/2017	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207925s001lbl.pdf
02/08/2017	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf
03/17/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf

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