Details for New Drug Application (NDA): 202714
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NDA 202714 describes KYPROLIS, which is a drug marketed by Onyx Pharms Amgen and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KYPROLIS profile page.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
Summary for 202714
| Tradename: | KYPROLIS |
| Applicant: | Onyx Pharms Amgen |
| Ingredient: | carfilzomib |
| Patents: | 11 |
Pharmacology for NDA: 202714
| Mechanism of Action | Proteasome Inhibitors |
Suppliers and Packaging for NDA: 202714
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-101 | 76075-101-01 | 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-01) / 30 mL in 1 VIAL, SINGLE-USE |
| KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-102 | 76075-102-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-01) / 15 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 60MG/VIAL | ||||
| Approval Date: | Jul 20, 2012 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 14, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 20, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 14, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY | ||||||||
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