Issued to scPharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 11, 2018Application
NDA 505b1 • 209988
Product
FUROSCIX
Company
scPharmaceuticals, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Device constituent and human factors, Chemistry, manufacturing, and controls, Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to scPharmaceuticals, Inc. on June 11, 2018.
NDA 209988 is the application under which FDA issued this complete response letter for FUROSCIX to scPharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated June 11, 2018.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.