Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219164
Company: ASCENDIS
Company: ASCENDIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YUVIWEL | NAVEPEGRITIDE | 1.3MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| YUVIWEL | NAVEPEGRITIDE | 2.8MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| YUVIWEL | NAVEPEGRITIDE | 5.5MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/27/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219164Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219164Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/27/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219164Orig1s000lbl.pdf |