scPharmaceuticals Inc. has resubmitted its NDA to the FDA for Furoscix for the treatment of congestion in patients with heart failure.

scPharmaceuticals Inc. announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the FDA seeking approval of Furoscix (subcutaneous furosemide) for the treatment of congestion in patients with heart failure. The NDA resubmission is intended to address concerns raised in the FDA’s June 2018 Complete Response Letter.

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. Furoscix has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.