FDA approved the original new drug application for ZORYVE on July 29, 2022, sponsored by ARCUTIS. FDA has approved 4 efficacy supplements on the application since, the most recent on June 29, 2026.
- Application
- NDA215985
- Sponsor
- ARCUTIS
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- roflumilast
Browse every approval whose brand starts with Z, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| roflumilast 0.05% | CREAM | TOPICAL | Prescription |
| roflumilast 0.3% | CREAM | TOPICAL | Prescription |
| roflumilast 0.15% | CREAM | TOPICAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard | |
| S-7 | standard | |
| S-12 | standard | |
| S-15 | standard |
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to ARCUTIS
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