Posted by Michael Wonder on 27 Jul 2020
scPharmaceuticals announces FDA acceptance of Furoscix new drug application resubmission
27 July 2020 - FDA sets PDUFA date of 30 December 2020.
scPharmaceuticals today announced that the U.S. FDA has accepted for review the company’s new drug application resubmission for Furoscix.
scPharmaceuticals is developing Furoscix, a proprietary, subcutaneously delivered furosemide solution, as an outpatient alternative for the treatment of worsening heart failure due to congestion.
The FDA indicated that this was a complete class 2 response and assigned a Prescription Drug User-Fee Act target action date of 30 December 2020.
