Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761445
Company: SANOFI-AVENTIS U.S. LLC
Company: SANOFI-AVENTIS U.S. LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SARCLISA ESCENA | ISATUXIMAB-IRFC | 1400MG/10ML (140MG/ML) | VIAL;SINGLE-DOSE | 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 |
|---|---|---|---|---|---|---|---|
| 07/09/2026 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761445Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761445Orig1s000Correctedltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/09/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761445Orig1s000lbl.pdf |