The Food and Drug Administration (FDA) has issued a complete response letter (CRL) to scPharmaceuticals regarding the New Drug Application (NDA) for Furoscix® (furosemide for subcutaneous injection) as an outpatient alternative for the treatment of worsening heart failure due to congestion.
While the CRL did not raise any clinical deficiencies, the FDA requested that the Company conduct pre-approval inspections at 2 of their third-party manufacturing facilities which could not be conducted due to travel restrictions. Moreover, the Agency noted issues related to testing, labeling, and features of the combination product unrelated to the drug constituent.
John Tucker, CEO of scPharmaceuticals, stated, “While we are disappointed that these on-site inspections, and other issues raised in the CRL, will not be resolved by our previously granted December 30, 2020 PDUFA date, we are committed to working with our manufacturing partners and responding to the agency’s concerns as expeditiously as possible.”
Furoscix is an investigational, proprietary, pH-neutral formulation of furosemide designed for subcutaneous administration via a wearable, preprogrammed on-body drug delivery system for outpatient self-administration. This is the second time the Company has received a CRL for the Furoscix application. In June 2018, the FDA issued a CRL indicating the need for additional human factors studies and device modifications.
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scPharmaceuticals Inc. receives complete response letter from FDA for Furoscix®. [press release]. Burlington, MA: scPharmaceuticals Inc; December 7, 2020.