Issued to PharmaEssentia Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 12, 2021Application
BLA • 761166
Product
BESREMI
Company
PharmaEssentia Corporation
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
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, Device constituent and human factors. 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 PharmaEssentia Corporation on March 12, 2021.
BLA 761166 is the application under which FDA issued this complete response letter for BESREMI to PharmaEssentia Corporation. It was reviewed by FDA Other. The letter is dated March 12, 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.