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Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA* injection in hemodialysis patients with moderate-to-severe pruritus


Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA injection in hemodialysis patients with moderate-to-severe pruritus
If approved, KORSUVA injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application. ....

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