FdaApplication
NDA 218785
Identifiers
- fda_app_no: NDA218785
Properties
| Property | Value |
|---|---|
| applicant_name | BEONE MEDICINES USA INC |
| application_type | NDA |
| approval_date | 2025-06-10 |
Revenue by product
BRUKINSA
| Period | Revenue |
|---|---|
| Q2 2026 | $1.2B |
| Q2 2025 | $949.8M |
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.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BRUKINSA | ZANUBRUTINIB | 80MG | CAPSULE;ORAL |
| BRUKINSA | ZANUBRUTINIB | 160MG | TABLET;ORAL |
2 products