FdaApplication
BLA 125320
Identifiers
- fda_app_no: BLA125320
Properties
| Property | Value |
|---|---|
| applicant_name | Amgen Inc. |
| application_type | BLA |
| approval_date | 2010-06-01 |
Revenue by product
PROLIA
| Period | Revenue |
|---|---|
| Q2 2026 | $759.0M |
| Q1 2026 | $727.0M |
| Q4 2025 | $1.1B |
| Q3 2025 | $1.1B |
| Q2 2025 | $1.1B |
| Q1 2025 | $1.1B |
| Q4 2024 | $1.2B |
| Q3 2024 | $1.0B |
| Q2 2024 | $1.2B |
| Q1 2024 | $999.0M |
| Q4 2023 | $1.1B |
| Q3 2023 | $986.0M |
| Q2 2023 | $1.0B |
| Q1 2023 | $927.0M |
| Q4 2022 | $992.0M |
| Q3 2022 | $862.0M |
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.
XGEVA
| Period | Revenue |
|---|---|
| Q2 2026 | $352.0M |
| Q1 2026 | $411.0M |
| Q4 2025 | $447.0M |
| Q3 2025 | $539.0M |
| Q2 2025 | $532.0M |
| Q1 2025 | $566.0M |
| Q4 2024 | $561.0M |
| Q3 2024 | $541.0M |
| Q2 2024 | $562.0M |
| Q1 2024 | $561.0M |
| Q4 2023 | $527.0M |
| Q3 2023 | $519.0M |
| Q2 2023 | $530.0M |
| Q1 2023 | $536.0M |
| Q4 2022 | $484.0M |
| Q3 2022 | $495.0M |
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.
XGEVA
| Period | Revenue |
|---|---|
| Q2 2026 | $352.0M |
| Q1 2026 | $411.0M |
| Q4 2025 | $447.0M |
| Q3 2025 | $539.0M |
| Q2 2025 | $532.0M |
| Q1 2025 | $566.0M |
| Q4 2024 | $561.0M |
| Q3 2024 | $541.0M |
| Q2 2024 | $562.0M |
| Q1 2024 | $561.0M |
| Q4 2023 | $527.0M |
| Q3 2023 | $519.0M |
| Q2 2023 | $530.0M |
| Q1 2023 | $536.0M |
| Q4 2022 | $484.0M |
| Q3 2022 | $495.0M |
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 (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROLIA | DENOSUMAB | 60MG/ML | INJECTABLE;SUBCUTANEOUS |
| PROLIA | DENOSUMAB | 60MG/ML | INJECTABLE;SUBCUTANEOUS |
| XGEVA | — | 120MG/1.7ML (70MG/ML) | Injection |
3 products