scPharmaceuticals Inc. issued the following announcement on July 27.
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®. 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.”
About FUROSCIX
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.
About scPharmaceuticals
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. For more information, please visit www.scPharmaceuticals.com.
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