Details for New Drug Application (NDA): 214916
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NDA 214916 describes KORSUVA, which is a drug marketed by Vifor Intl and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the KORSUVA profile page.
The generic ingredient in KORSUVA is difelikefalin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the difelikefalin acetate profile page.
The generic ingredient in KORSUVA is difelikefalin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the difelikefalin acetate profile page.
Summary for 214916
| Tradename: | KORSUVA |
| Applicant: | Vifor Intl |
| Ingredient: | difelikefalin acetate |
| Patents: | 12 |
Pharmacology for NDA: 214916
| Mechanism of Action | Opioid kappa Receptor Agonists |
Suppliers and Packaging for NDA: 214916
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KORSUVA | difelikefalin acetate | SOLUTION;INTRAVENOUS | 214916 | NDA | Vifor (International), Inc. | 59353-065 | 59353-065-12 | 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Aug 23, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,017,536 | Patent Expiration: | Nov 12, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) | ||||||||
| Patent: | 10,138,270 | Patent Expiration: | Nov 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) | ||||||||
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