Issued to medac Gesellschaft fur klinische Spezialpraparate mbH. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 30, 2021Application
NDA 505b1 • 214759
Product
GRAFAPEX
Company
medac Gesellschaft fur klinische Spezialpraparate mbH
Review center
Other
Stage
Final Decision
Response due
January 1, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. 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 medac Gesellschaft fur klinische Spezialpraparate mbH on July 30, 2021.
NDA 214759 is the application under which FDA issued this complete response letter for GRAFAPEX to medac Gesellschaft fur klinische Spezialpraparate mbH. It was reviewed by FDA Other. The letter is dated July 30, 2021.
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.