FdaApplication
NDA 215985
Identifiers
- fda_app_no: NDA215985
Properties
| Property | Value |
|---|---|
| applicant_name | ARCUTIS BIOTHERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2022-07-29 |
Revenue by product
ZORYVE
| Period | Revenue |
|---|---|
| Q2 2026 | $129.9M |
| Q1 2026 | $105.4M |
| Q4 2025 | $126.6M |
| Q3 2025 | $99.2M |
| Q2 2025 | $81.5M |
| Q1 2025 | $87.2M |
| Q4 2024 | $69.4M |
| Q3 2024 | $44.8M |
| Q2 2024 | $48.1M |
| Q1 2024 | $21.6M |
| Q4 2023 | $13.5M |
| Q3 2023 | $8.1M |
| Q2 2023 | $4.8M |
| Q1 2023 | $2.8M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZORYVE | ROFLUMILAST | 0.3% | CREAM;TOPICAL |
| ZORYVE | ROFLUMILAST | 0.15% | CREAM;TOPICAL |
| ZORYVE | ROFLUMILAST | 0.05% | CREAM;TOPICAL |
3 products