FdaApplication
NDA 212097
Identifiers
- fda_app_no: NDA212097
Properties
| Property | Value |
|---|---|
| applicant_name | XERIS PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2019-09-10 |
Revenue by product
GVOKE HYPOPEN
| Period | Revenue |
|---|---|
| Q2 2026 | $22.5M |
| Q1 2026 | $20.8M |
| Q4 2025 | $24.6M |
| Q3 2025 | $25.2M |
| Q2 2025 | $23.5M |
| Q1 2025 | $20.8M |
| Q4 2024 | $23.3M |
| Q3 2024 | $22.9M |
| Q2 2024 | $20.0M |
| Q1 2024 | $16.6M |
| Q4 2023 | $18.6M |
| Q3 2023 | $17.7M |
| Q2 2023 | $15.6M |
| Q1 2023 | $15.0M |
| Q4 2022 | $14.9M |
| Q3 2022 | $13.7M |
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.
GVOKE KIT
| Period | Revenue |
|---|---|
| Q2 2026 | $22.5M |
| Q1 2026 | $20.8M |
| Q4 2025 | $24.6M |
| Q3 2025 | $25.2M |
| Q2 2025 | $23.5M |
| Q1 2025 | $20.8M |
| Q4 2024 | $23.3M |
| Q3 2024 | $22.9M |
| Q2 2024 | $20.0M |
| Q1 2024 | $16.6M |
| Q4 2023 | $18.6M |
| Q3 2023 | $17.7M |
| Q2 2023 | $15.6M |
| Q1 2023 | $15.0M |
| Q4 2022 | $14.9M |
| Q3 2022 | $13.7M |
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.
GVOKE PFS
| Period | Revenue |
|---|---|
| Q2 2026 | $22.5M |
| Q1 2026 | $20.8M |
| Q4 2025 | $24.6M |
| Q3 2025 | $25.2M |
| Q2 2025 | $23.5M |
| Q1 2025 | $20.8M |
| Q4 2024 | $23.3M |
| Q3 2024 | $22.9M |
| Q2 2024 | $20.0M |
| Q1 2024 | $16.6M |
| Q4 2023 | $18.6M |
| Q3 2023 | $17.7M |
| Q2 2023 | $15.6M |
| Q1 2023 | $15.0M |
| Q4 2022 | $14.9M |
| Q3 2022 | $13.7M |
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.
GVOKE VIALDX
| Period | Revenue |
|---|---|
| Q2 2026 | $22.5M |
| Q1 2026 | $20.8M |
| Q4 2025 | $24.6M |
| Q3 2025 | $25.2M |
| Q2 2025 | $23.5M |
| Q1 2025 | $20.8M |
| Q4 2024 | $23.3M |
| Q3 2024 | $22.9M |
| Q2 2024 | $20.0M |
| Q1 2024 | $16.6M |
| Q4 2023 | $18.6M |
| Q3 2023 | $17.7M |
| Q2 2023 | $15.6M |
| Q1 2023 | $15.0M |
| Q4 2022 | $14.9M |
| Q3 2022 | $13.7M |
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 (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GVOKE HYPOPEN | GLUCAGON | 1MG/0.2ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS |
| GVOKE HYPOPEN | GLUCAGON | 0.5MG/0.1ML (0.5MG/0.1ML) | SOLUTION;SUBCUTANEOUS |
| GVOKE KIT | GLUCAGON | 1MG/0.2ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS |
| GVOKE PFS | GLUCAGON | 0.5MG/0.1ML (0.5MG/0.1ML) | SOLUTION;SUBCUTANEOUS |
| GVOKE PFS | GLUCAGON | 1MG/0.2ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS |
| GVOKE VIALDX | GLUCAGON | 1MG/0.2ML (1MG/0.2ML) | SOLUTION;INTRAVENOUS |
6 products