Benzinga | Jul 27, 2020 08:11AM EDT

scPharmaceuticals Announces FDA Acceptance Of FUROSCIX New Drug Application Resubmission; FDA Sets PDUFA Date Of December 30, 2020

FDA sets PDUFA date of December 30, 2020

scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) resubmission for FUROSCIX(r). 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.

"The FDA's acceptance of our FUROSCIX NDA resubmission is a significant achievement for our company. We believe we have successfully addressed the questions and concerns previously raised by the agency in its 2018 Complete Response Letter and we look forward to working with the agency during its review process," said John Tucker, president and chief executive officer of scPharmaceuticals. "If approved, we believe FUROSCIX has the potential to benefit patients and payers alike and provide physicians a new tool in the battle to treat worsening heart failure."