FdaApplication
NDA 207925
Identifiers
- fda_app_no: NDA207925
Properties
| Property | Value |
|---|---|
| applicant_name | VERTEX PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2015-03-17 |
Revenue by product
KALYDECO
| Period | Revenue |
|---|---|
| Q4 2023 | $112.4M |
| Q3 2023 | $112.8M |
| Q4 2022 | $136.1M |
| Q3 2022 | $139.4M |
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 (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KALYDECO | IVACAFTOR | 25MG/PACKET | GRANULE;ORAL |
| KALYDECO | IVACAFTOR | 13.4MG/PACKET | GRANULE;ORAL |
| KALYDECO | IVACAFTOR | 50MG/PACKET | GRANULE;ORAL |
| KALYDECO | IVACAFTOR | 75MG/PACKET | GRANULE;ORAL |
| KALYDECO | IVACAFTOR | 5.8MG/PACKET | GRANULE;ORAL |
5 products