Issued to Delcath Systems, Incorporated. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 12, 2013Application
NDA 505b1 • 201848
Product
HEPZATO
Company
Delcath Systems, Incorporated
Review center
Other
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Labeling, packaging, and proprietary name, Safety and adverse events. 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 Delcath Systems, Incorporated on September 12, 2013.
NDA 201848 is the application under which FDA issued this complete response letter for HEPZATO to Delcath Systems, Incorporated. It was reviewed by FDA Other. The letter is dated September 12, 2013.
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.