FdaApplication
NDA 011366
Identifiers
- fda_app_no: NDA011366
Properties
| Property | Value |
|---|---|
| applicant_name | XERIS PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2015-08-07 |
Revenue by product
KEVEYIS
| Period | Revenue |
|---|---|
| Q2 2026 | $11.7M |
| Q1 2026 | $11.9M |
| Q4 2025 | $12.8M |
| Q3 2025 | $11.9M |
| Q2 2025 | $11.5M |
| Q1 2025 | $11.4M |
| Q4 2024 | $11.1M |
| Q3 2024 | $12.2M |
| Q2 2024 | $13.1M |
| Q1 2024 | $13.1M |
| Q4 2023 | $14.1M |
| Q3 2023 | $15.9M |
| Q2 2023 | $14.1M |
| Q1 2023 | $12.8M |
| Q4 2022 | $13.8M |
| Q3 2022 | $13.4M |
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 (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DARANIDE | DICHLORPHENAMIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| KEVEYIS | DICHLORPHENAMIDE | 50MG | TABLET;ORAL |
2 products