Issued to Tanvex BioPharma USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 20, 2021Application
BLA • 761126
Product
NYPOZI
Company
Tanvex BioPharma USA, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2026
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Facility inspection and CGMP compliance, Data integrity and reliability. 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Tanvex BioPharma USA, Inc. on May 20, 2021.
BLA 761126 is the application under which FDA issued this complete response letter for NYPOZI to Tanvex BioPharma USA, Inc.. It was reviewed by FDA Other. The letter is dated May 20, 2021.
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.