Rebounding from the Complete Response Letter (CRL) it received in June 2018, scPharmaceuticals (NASDAQ:SCPH) has resubmitted its U.S. marketing application seeking approval of Furoscix (subcutaneous furosemide) for the treatment of congestion in heart failure patients.
The CRL cited the need for additional human factor studies and device modifications.
Furoscix is a pH-neutral solution of the diuretic furosemide that is administered via subcutaneous infusion by a wearable injector that is part of an integrated drug delivery system.
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