FDA Approval for VUMERITY issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 211855
Company: BIOGEN INC
Company: BIOGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VUMERITY | DIROXIMEL FUMARATE | 231MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/29/2019 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211855Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211855Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2024 | SUPPL-17 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s017lbl.pdf | ||
| 12/13/2023 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s016ltr.pdf | |
| 03/22/2024 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211855Orig1s015ltr.pdf | |
| 11/16/2022 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s011ltr.pdf | |
| 09/29/2022 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855s010lbl.pdf | |
| 02/10/2023 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s009ltr.pdf | |
| 02/10/2022 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s006ltr.pdf | |
| 01/29/2021 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211855s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211855Orig1s004ltr.pdf | |
| 08/21/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211855Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/11/2024 | SUPPL-17 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s017lbl.pdf | |
| 03/22/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s015lbl.pdf | |
| 12/13/2023 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s016lbl.pdf | |
| 02/10/2023 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s009lbl.pdf | |
| 11/16/2022 | SUPPL-11 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855Orig1s011lbl.pdf | |
| 09/29/2022 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s010lbl.pdf | |
| 02/10/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s006lbl.pdf | |
| 01/29/2021 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211855s004lbl.pdf | |
| 08/21/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf | |
| 08/21/2020 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf | |
| 10/29/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf |