FDA issues Complete Response Letter for Furoscix a treatment for edema, or fluid overload, in patients with heart failure.-sc Pharmaceuticals

scPharmaceuticals Inc. announced it received a Complete Response Letter (“CRL”) from the FDA regarding the Company’s New Drug Application (“NDA”) for Furoscix , a treatment candidate for edema, or fluid overload, in patients with heart failure. In the CRL, the FDA cited their need to conduct pre-approval inspections at two of the company’s third-party manufacturing facilities that could not be conducted due to travel restrictions. In addition, the FDA raised questions related to testing, labeling, and features of the combination product unrelated to the drug constituent. In addition, the FDA indicated that there were deficiencies at the third-party facility where the Company’s off-the-shelf alcohol swabs are manufactured. scPharmaceuticals will request a Type A meeting with the FDA to discuss the issues described in the CRL and steps required for the resubmission of the NDA forFuroscix..