Issued to Citius Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 28, 2023Application
BLA • 761312
Product
LYMPHIR
Company
Citius Pharmaceuticals, Inc.
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. 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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Citius Pharmaceuticals, Inc. on July 28, 2023.
BLA 761312 is the application under which FDA issued this complete response letter for LYMPHIR to Citius Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated July 28, 2023.
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.