Issued to Bristol-Myers Squibb. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 17, 2012Application
NDA 505b1 • 202293
Product
FARXIGA
Company
Bristol-Myers Squibb
Stage
Final Decision
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Bristol-Myers Squibb on January 17, 2012.
NDA 202293 is the application under which FDA issued this complete response letter for FARXIGA to Bristol-Myers Squibb. The letter is dated January 17, 2012.
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.