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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205755
Company: NOVARTIS

Summary Review

Products on NDA 205755

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYKADIA	CERITINIB	150MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205755

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2014	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/2014/205755s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2021	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205755s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205755Orig1s019ltr.pdf
08/19/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205755s018.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205755Orig1s018ltr.pdf
03/05/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205755s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205755Orig1s016ltr_REPLACEMENT.pdf
07/19/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s012ltr.pdf
11/20/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s011ltr.pdf
12/21/2017	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s010ltr.pdf
05/26/2017	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s009ltr.pdf
09/07/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205755Orig1s006ltr.pdf
08/25/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/22/2015	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf
07/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf
06/24/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205755

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205755s019lbl.pdf
10/07/2021	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205755s019lbl.pdf
08/19/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205755s018.pdf
03/05/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205755s016lbl.pdf
12/21/2017	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s010lbl.pdf
11/20/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s011lbl.pdf
07/19/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s012lbl.pdf
05/26/2017	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf
09/07/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf
07/22/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
07/22/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
07/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
04/29/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755s000lbl.pdf

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