FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 217242
Company: ARCUTIS BIOTHERAPEUTICS INC
Company: ARCUTIS BIOTHERAPEUTICS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZORYVE | ROFLUMILAST | 0.3% | Foam | 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 |
|---|---|---|---|---|---|---|---|
| 12/15/2023 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217242s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217242Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217242s000lbl.pdf |