Issued to Kyowa Pharmaceutical, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 25, 2008Application
NDA 505b1 • 022075
Product
NOURIANZ
Company
Kyowa Pharmaceutical, Inc.
Review center
Other
Stage
Final Decision
Response due
November 23, 2025
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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 Kyowa Pharmaceutical, Inc. on February 25, 2008.
NDA 022075 is the application under which FDA issued this complete response letter for NOURIANZ to Kyowa Pharmaceutical, Inc.. It was reviewed by FDA Other. The letter is dated February 25, 2008.
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.