Issued to Novartis Pharmaceuticals Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 18, 2020Application
NDA 505b1 • 214012
Product
LEQVIO
Company
Novartis Pharmaceuticals Corporation
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. 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 Novartis Pharmaceuticals Corporation on December 18, 2020.
NDA 214012 is the application under which FDA issued this complete response letter for LEQVIO to Novartis Pharmaceuticals Corporation. It was reviewed by FDA Other. The letter is dated December 18, 2020.
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.