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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. ....

Vifor Pharma , Julien Vignot , Claire Lacagnina , Janhavi Mohite , Derek Chalmers , Stefan Schulze , Nathalie Ponnier , Stern Investor Relations Inc , Swiss Stock Exchange , Drug Administration , Global Head Corporate Communications , Swiss Exchange , International Journal Of Nephrology , Exchange Commission , Cara Therapeutics Inc , Vifor Pharma Group , National Registry Study , Fresenius Medical Care , Prescription Drug User Fee Act , Cara Therapeutics , Priority Review , New Drug Application , New England Journal , Chief Executive Officer , Chronic Kidney Disease Associated Pruritus , Registry Study ,

Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for .
Cara Therapeutics, Inc.March 8, 2021 GMT
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma 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 August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeti ....

Vifor Pharma , Julien Vignot , Claire Lacagnina , Janhavi Mohite , Derek Chalmers , Stefan Schulze , Nathalie Ponnier , Stern Investor Relations Inc , Swiss Stock Exchange , Drug Administration , Global Head Corporate Communications , Swiss Exchange , International Journal Of Nephrology , Exchange Commission , Vifor Pharma Group , National Registry Study , Fresenius Medical Care , Vifor Pharma Group Contacts , Prescription Drug User Fee Act , Priority Review , New Drug Application , New England Journal , Chief Executive Officer , Cara Therapeutics , Chronic Kidney Disease Associated Pruritus , Registry Study ,

Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus

TMCnet News
Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
[December 28, 2020]
Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
First NDA submission for Companyâs lead program, KORSUVAâ¢ Injection â
NDA submission includes request for Priority Review under Breakthrough Therapy Designation for KORSUVA Injection â
STAMFORD, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ....

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