Issued to Galephar Pharmaceutical Research Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 5, 2023Application
NDA 505b1 • 215040
Product
LEGUBETI
Company
Galephar Pharmaceutical Research Inc.
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. 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 Galephar Pharmaceutical Research Inc. on May 5, 2023.
NDA 215040 is the application under which FDA issued this complete response letter for LEGUBETI to Galephar Pharmaceutical Research Inc.. It was reviewed by FDA Other. The letter is dated May 5, 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.