FDA Approval for TOUJEO MAX SOLOSTAR issued to SANOFI US SERVICES
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 206538
Company: SANOFI US SERVICES
Company: SANOFI US SERVICES
| 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 |
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 |
|---|---|---|---|---|---|
| 08/29/2024 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206538Orig1s017Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206538Orig1s017ltr.pdf | |
| 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2024 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206538Orig1s017Lbl.pdf | |
| 08/16/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206538s016lbl.pdf | |
| 08/16/2022 | SUPPL-16 | Labeling-Container/Carton Labels | 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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.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-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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.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-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206538s010s011lbl.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-Container/Carton Labels | 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 |