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Details for New Drug Application (NDA): 207925
NDA 207925 describes KALYDECO, which is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KALYDECO profile page.
The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
Summary for 207925
| Tradename: | KALYDECO |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | ivacaftor |
| Patents: | 8 |
Suppliers and Packaging for NDA: 207925
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-300 | N | 51167-300-01 |
| KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-400 | N | 51167-400-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 50MG/PACKET | ||||
| Approval Date: | Mar 17, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 31, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jan 31, 2019 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A G551D MUTATION IN THE CFTR GENE. | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | May 20, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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