Issued to Ferring Pharmaceuticals Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 30, 2013Application
NDA 505b1 • 022517
Product
NOCDURNA
Company
Ferring Pharmaceuticals Inc.
Review center
Other
Stage
Final Decision
Response due
November 13, 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, Safety and adverse events, 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 Ferring Pharmaceuticals Inc. on January 30, 2013.
NDA 022517 is the application under which FDA issued this complete response letter for NOCDURNA to Ferring Pharmaceuticals Inc.. It was reviewed by FDA Other. The letter is dated January 30, 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.