FDA accepts for review NDA for furoscix to treat congestive heart failure.- scPharmaceuticals
scPharmaceuticals Inc. announced that the FDA has accepted for review the company’s New Drug Application (NDA) 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 (PDUFA) target action date of December 30, 2020.
Furoscix is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. Furoscix is being developed for treatment of congestion, or fluid overload, in patients with heart failure.