FDA Approval for VAFSEO issued to AKEBIA THERAPEUTICS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215192
Company: AKEBIA THERAPEUTICS INC
Company: AKEBIA THERAPEUTICS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VAFSEO | VADADUSTAT | 150MG | TABLET; ORAL | Prescription | None | No | No |
| VAFSEO | VADADUSTAT | 300MG | TABLET; ORAL | Prescription | None | No | No |
| VAFSEO | VADADUSTAT | 450MG | TABLET; 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 |
|---|---|---|---|---|---|---|---|
| 03/27/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215192Orig1s000ltr.pdf |