An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209092
Company: NOVARTIS

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
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
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

Top