Issued to Amryt Pharmaceuticals DAC. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 26, 2022Application
NDA 505b1 • 215064
Product
FILSUVEZ
Company
Amryt Pharmaceuticals DAC
Review center
Other
Stage
Final Decision
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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. 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 Amryt Pharmaceuticals DAC on February 26, 2022.
NDA 215064 is the application under which FDA issued this complete response letter for FILSUVEZ to Amryt Pharmaceuticals DAC. It was reviewed by FDA Other. The letter is dated February 26, 2022.
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.