Issued to Bioprojet Pharma. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 14, 2019Application
NDA 505b1 • 211150
Product
WAKIX
Company
Bioprojet Pharma
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, Labeling, packaging, and proprietary name, 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 Bioprojet Pharma on August 14, 2019.
NDA 211150 is the application under which FDA issued this complete response letter for WAKIX to Bioprojet Pharma. It was reviewed by FDA Other. The letter is dated August 14, 2019.
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.