FdaApplication
NDA 211358
Identifiers
- fda_app_no: NDA211358
Properties
| Property | Value |
|---|---|
| applicant_name | VERTEX PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2018-08-07 |
Revenue by product
ORKAMBI
| Period | Revenue |
|---|---|
| Q4 2023 | $44.2M* |
| Q3 2023 | $63.0M* |
| Q4 2022 | $110.8M* |
| Q3 2022 | $146.2M* |
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 (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 188MG/PACKET;150MG/PACKET | GRANULE;ORAL |
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 94MG/PACKET;75MG/PACKET | GRANULE;ORAL |
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 125MG/PACKET;100MG/PACKET | GRANULE;ORAL |
3 products