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

Biologic License Application (BLA): 125469
Company: ELI LILLY AND CO

Medication Guide

Summary Review

Products on BLA 125469

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRULICITY	DULAGLUTIDE	0.75MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
TRULICITY	DULAGLUTIDE	1.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	TBD	No
TRULICITY	DULAGLUTIDE	3MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
TRULICITY	DULAGLUTIDE	4.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125469

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2014	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2022	SUPPL-52	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf
11/17/2022	SUPPL-51	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s051ltr.pdf
06/10/2022	SUPPL-46	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf
09/30/2021	SUPPL-44	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125469Orig1s044ltr.pdf
09/03/2020	SUPPL-36	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s036ltr.pdf
02/21/2020	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s033ltr.pdf
09/21/2018	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s024ltr.pdf
01/15/2019	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125469Orig1s023ltr.pdf
12/12/2017	SUPPL-21	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s021ltr.pdf
06/29/2018	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s017ltr.pdf
08/01/2017	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf
08/01/2017	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf
01/27/2017	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf
01/27/2017	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf
07/27/2015	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf
12/19/2014	SUPPL-2	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf
03/09/2015	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf

Labels for BLA 125469

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2022	SUPPL-51	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf
06/10/2022	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf
06/10/2022	SUPPL-52	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf
06/10/2022	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf
09/30/2021	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf
09/03/2020	SUPPL-36	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf
02/21/2020	SUPPL-33	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf
01/15/2019	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf
09/21/2018	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf
06/29/2018	SUPPL-17	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf
08/01/2017	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf
08/01/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf
01/27/2017	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf
01/27/2017	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf
09/18/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf

Top