29 July 2020 - - The US Food and Drug Administration has accepted for review US-based pharmaceutical company scPharmaceuticals Inc's (NASDAQ: SCPH) New Drug Application resubmission for Furoscix, the company said.

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.

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

scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes.

The company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions.

The company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease.

scPharmaceuticals is headquartered in Burlington, MA.