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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208716
Company: ELI LILLY AND CO

Products on NDA 208716

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERZENIO	ABEMACICLIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
VERZENIO	ABEMACICLIB	100MG	TABLET;ORAL	Prescription	None	Yes	No
VERZENIO	ABEMACICLIB	150MG	TABLET;ORAL	Prescription	None	Yes	No
VERZENIO	ABEMACICLIB	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208716Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208716Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2023	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208716Orig1s010,s011ltr.pdf
03/03/2023	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208716Orig1s010,s011ltr.pdf
10/12/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208716Orig1s006,s007,s008ltr.pdf
10/12/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208716Orig1s006,s007,s008ltr.pdf
10/12/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208716Orig1s006,s007,s008ltr.pdf
03/30/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208716s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208716Orig1s004ltr.pdf
09/09/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208716s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208716Orig1s003ltr.pdf
08/17/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208716s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208716Orig1s001ltr.pdf

Labels for NDA 208716

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2023	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf
03/03/2023	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf
10/12/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf
10/12/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf
10/12/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf
03/30/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208716s004lbl.pdf
09/09/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208716s003lbl.pdf
09/09/2019	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208716s003lbl.pdf
08/17/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208716s001lbl.pdf
09/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf

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