FDA Approval for MIRVETUXIMAB SORAVTANSINE issued to IMMUNOGEN INC
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761310
Company: IMMUNOGEN INC
Company: IMMUNOGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRVETUXIMAB SORAVTANSINE | MIRVETUXIMAB SORAVTANSINE | 100 mg/20 mL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/14/2022 | ORIG-1 | Approval | N/A |
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