Issued to The Feinstein Institute for Medical Research. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 15, 2016Application
NDA 505b1 • 200655
Product
FLUORODOPA F18
Company
The Feinstein Institute for Medical Research
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to The Feinstein Institute for Medical Research on September 15, 2016.
NDA 200655 is the application under which FDA issued this complete response letter for FLUORODOPA F18 to The Feinstein Institute for Medical Research. It was reviewed by FDA Other. The letter is dated September 15, 2016.
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.