Posted by Michael Wonder on 14 Jun 2018
scPharmaceuticals receives complete response letter from the FDA for Furoscix
13 June 2018 - scPharmaceuticals today announced the Company received a complete response letter from the U.S. FDA regarding the 505(b)(2) application for Furoscix, a treatment candidate for oedema, or fluid overload, in patients with heart failure.
The letter indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study. scPharmaceuticals intends to request a meeting with the FDA to further evaluate the deficiencies raised.
