Drug news

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

Read time: 1 mins

Last updated:17th Jun 2018

Published:17th Jun 2018

Source: Pharmawand

scPharmaceuticals Inc., announced the Company received a Complete Response Letter (CRL) from the FDA regarding the 505(b)(2) application for Furoscix, a treatment candidate for edema, or fluid overload, in patients with heart failure. The CRL 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..

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