Posted by Michael Wonder on 08 Mar 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and priority review of NDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
8 March 2021 - FDA has set Prescription Drug User Fee Act target action date of 23 August 2021.
Cara Therapeutics and Vifor Pharma today announced that the U.S. FDA has accepted and granted priority review for the new drug application for Korsuva (difelikefalin) solution for injection for the treatment of moderate to severe pruritus in haemodialysis patients.
The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.
