FdaApplication
NDA 219776
Identifiers
- fda_app_no: NDA219776
Properties
| Property | Value |
|---|---|
| applicant_name | BIOCRYST PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2025-12-11 |
Revenue by product
ORLADEYO
| Period | Revenue |
|---|---|
| Q3 2024 | $116.3M |
| Q3 2023 | $85.7M |
| Q3 2022 | $66.0M |
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.
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 72MG BASE/PACKET | PELLETS;ORAL |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 108MG BASE/PACKET | PELLETS;ORAL |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 132MG BASE/PACKET | PELLETS;ORAL |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 96MG BASE/PACKET | PELLETS;ORAL |
4 products