FDA Approval for VUMERITY issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 761347
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 | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2024 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761347s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/12/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761347s000lbl.pdf |