Travere Therapeutics Submits sNDA To FDA For Approval Of Filspari (Sparsentan) For The Treatment Of FSGS
Reuters
03-17
March 17 (Reuters) - Travere Therapeutics Inc :: *TRAVERE THERAPEUTICS SUBMITS SNDA TO FDA FOR APPROVAL OF FILSPARI® (SPARSENTAN) FOR THE TREATMENT OF FSGS *TRAVERE THERAPEUTICS INC: FDA NOTIFIED COMPANY THAT REMS MONITORING FOR EMBRYO-FETAL TOXICITY IS NO LONGER NECESSARY *TRAVERE THERAPEUTICS INC: PLANS TO SUBMIT AMENDMENT TO REMS SNDA CURRENTLY UNDER REVIEW FOR MODIFICATION OF LIVER MONITORING *TRAVERE THERAPEUTICS INC: CONTINUES TO EXPECT A REMS MODIFICATION PDUFA TARGET ACTION DATE OF AUGUST 28