Issued to Institut Biochimique SA (IBSA). Application reviewed but not approved; deficiencies must be corrected.
Issued
March 24, 2017Application
NDA 505b1 • 206976
Product
LICART
Company
Institut Biochimique SA (IBSA)
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Nonclinical 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 Institut Biochimique SA (IBSA) on March 24, 2017.
NDA 206976 is the application under which FDA issued this complete response letter for LICART to Institut Biochimique SA (IBSA). It was reviewed by FDA Other. The letter is dated March 24, 2017.
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.