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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 206538
Company: SANOFI US SERVICES

Summary Review

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 206538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOUJEO MAX SOLOSTAR	INSULIN GLARGINE RECOMBINANT	900 UNITS/3ML (300 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No
TOUJEO SOLOSTAR	INSULIN GLARGINE RECOMBINANT	450 UNITS/1.5ML (300 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 206538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206538s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206538Orig1s016ltr.pdf
11/15/2019	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
11/15/2019	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf
11/26/2019	SUPPL-12	Supplement	Label (PDF) Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206538Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s012lbl.pdf
10/25/2018	SUPPL-11	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018	SUPPL-10	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
03/26/2018	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206538Orig1s006ltr.pdf
11/23/2016	SUPPL-3	Supplement		Label is not available on this site.
02/16/2016	SUPPL-2	Supplement		Label is not available on this site.
09/29/2015	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s001lbl.pdf

Labels for BLA 206538

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206538s016lbl.pdf
08/16/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206538s016lbl.pdf
11/26/2019	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206538Orig1s012ltr.pdf
11/26/2019	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s012lbl.pdf
11/15/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
11/15/2019	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
11/15/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
11/15/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf
10/25/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
10/25/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.pdf
03/26/2018	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
03/26/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
03/26/2018	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s006lbl.pdf
02/25/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf

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