Brief: Ardelyx Announces FDA Acceptance And Six-Month Review For Resubmission Of Its New Drug Application Of XPHOZAH

Ardelyx

17/05/2023 12:35

May 17 (Reuters) - Ardelyx Inc  ARDX.O :
    * ARDELYX ANNOUNCES FDA ACCEPTANCE AND SIX-MONTH REVIEW FOR
RESUBMISSION OF ITS NEW DRUG APPLICATION OF XPHOZAH® (TENAPANOR)
    * ARDELYX INC - FDA HAS SET A USER FEE GOAL DATE OF OCTOBER
17,
2023
    * ARDELYX INC - EXPECTS XPHOZAH TO BE COMMERCIALLY AVAILABLE
IN Q4
OF 2023, AS SOON AS POSSIBLE FOLLOWING AN APPROVAL FROM FDA
    * ARDELYX INC - FDA HAS DETERMINED THAT NDA IS A CLASS 2
REVIEW

Source text for Eikon:  ID:nGNX3B2sRb 
Further company coverage:  ARDX.O 

 ((Reuters.Brief@thomsonreuters.com;))