Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219666
Company: PTC THERAP
Company: PTC THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEPHIENCE | SEPIAPTERIN | 250MG/PACKET | POWDER;ORAL | Prescription | None | Yes | No |
| SEPHIENCE | SEPIAPTERIN | 1GM/PACKET | POWDER;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2025 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219666s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219666Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219666Orig1s000TOC.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219666s000lbl.pdf |