FDA Approval for ZURZUVAE issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 217369
Company: BIOGEN INC
Company: BIOGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZURZUVAE | ZURANOLONE | 20MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| ZURZUVAE | ZURANOLONE | 25MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| ZURZUVAE | ZURANOLONE | 30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|
| 08/04/2023 | ORIG-2 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Federal Register Notice
Label (PDF) Letter (PDF) Review |
FR Notice of DEA Scheduling; Date of Approval – October 31, 2023 |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
|---|---|---|---|---|
| 04/20/2026 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
| 07/31/2024 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note |
|---|---|---|---|---|
| 07/31/2024 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | |
| 07/31/2024 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | |
| 07/31/2024 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | |
| 08/04/2023 | ORIG-2 | Approval | Label (PDF) |