Source facts
FDA issued a complete response letter. No controlled deficiency theme met the deterministic text-matching threshold; review the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
AVACLYR — FDA Complete Response Letter (NDA 202408)
Issued to Fera Pharmaceuticals, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 28, 2019Application
NDA 505b1 • 202408
Product
AVACLYR
Company
Fera Pharmaceuticals, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
FreeWhat did FDA decide for AVACLYR?
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Key details in this letter
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Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the AVACLYR complete response letter
What does this complete response letter mean for AVACLYR?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Fera Pharmaceuticals, LLC on March 28, 2019.
What is NDA 202408?
NDA 202408 is the application under which FDA issued this complete response letter for AVACLYR to Fera Pharmaceuticals, LLC. It was reviewed by FDA Other. The letter is dated March 28, 2019.
What happens after an FDA complete response letter?
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.