FDA Approval for PYRUKYND issued to AGIOS PHARMACEUTICALS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 216196
Company: AGIOS PHARMACEUTICALS INC
Company: AGIOS PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PYRUKYND | MITAPIVAT | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/17/2022 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
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