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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209092
Company: NOVARTIS

Summary Review

Products on NDA 209092

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KISQALI	RIBOCICLIB SUCCINATE	EQ 200MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209092

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209092s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209092Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2024	SUPPL-20	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s020, 209935Orig1s028ltr.pdf
07/22/2024	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s019ltr.pdf
09/17/2024	SUPPL-18	Efficacy-New Indication	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s018, 209935Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209092s018,209935s027MultidisciplineR.pdf
08/24/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209092s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209092Orig1s016;209935Orig1s025ltr.pdf
10/03/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209092Orig1s013,209935Orig1s021ltr.pdf
09/15/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s009; 209935Orig1s013ltr.pdf
12/10/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s008;209935Orig1s014ltr.pdf
07/06/2020	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s005, 209935Orig1s008ltr.pdf
09/09/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209092s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209092Orig1s004ltr.pdf
01/21/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s003, 209935Orig1s006ltr.pdf
07/18/2018	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209092s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209092Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209092Orig1s001.pdf

Labels for NDA 209092

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2024	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf
09/03/2024	SUPPL-20	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf
07/22/2024	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092s019lbl.pdf
08/24/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209092s016lbl.pdf
10/03/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf
12/10/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf
09/15/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s009lbl.pdf
07/06/2020	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s005lbl.pdf
01/21/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s003lbl.pdf
09/09/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209092s004lbl.pdf
07/18/2018	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209092s001lbl.pdf
03/13/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf

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