FDA Approval for ADUHELM issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761178
Company: BIOGEN INC
Company: BIOGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADUHELM | ADUCANUMAB-AVWA | 170MG/1.7ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | None | TBD | No |
| ADUHELM | ADUCANUMAB-AVWA | 300MG/3ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 06/07/2021 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761178Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/08/2023 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 04/29/2022 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761178s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761178Orig1s005ltr.pdf | |
| 07/07/2021 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761178Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761178s005lbl.pdf | |
| 04/29/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761178s005lbl.pdf | |
| 07/07/2021 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s003lbl.pdf | |
| 07/07/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s003lbl.pdf | |
| 06/07/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf |