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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
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
Monday, March 8, 2021 1:10PM IST (7:40AM GMT)
 
St. Gallen, Switzerland & Stamford, Conn., United States:
  
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of 23 August 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
 
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 ....

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