FdaApplication
NDA 210745
Identifiers
- fda_app_no: NDA210745
Properties
| Property | Value |
|---|---|
| applicant_name | AMGEN INC |
| application_type | NDA |
| approval_date | 2025-08-29 |
Revenue by product
OTEZLA
| Period | Revenue |
|---|---|
| Q2 2026 | $491.0M |
| Q1 2026 | $431.0M |
| Q4 2025 | $625.0M |
| Q3 2025 | $585.0M |
| Q2 2025 | $618.0M |
| Q1 2025 | $437.0M |
| Q4 2024 | $624.0M |
| Q3 2024 | $564.0M |
| Q2 2024 | $544.0M |
| Q1 2024 | $394.0M |
| Q4 2023 | $629.0M |
| Q3 2023 | $567.0M |
| Q2 2023 | $600.0M |
| Q1 2023 | $392.0M |
| Q4 2022 | $616.0M |
| Q3 2022 | $627.0M |
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 (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OTEZLA | APREMILAST | 30MG | TABLET;ORAL |
| OTEZLA | APREMILAST | 20MG | TABLET;ORAL |
| OTEZLA | APREMILAST | 10MG | TABLET;ORAL |
| OTEZLA XR | APREMILAST | 75MG | TABLET, EXTENDED RELEASE;ORAL |
4 products