Issued to lpsen Biopharmaceuticals Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 23, 2022Application
NDA 505b1 • 215559
Product
SOHONOS
Company
lpsen Biopharmaceuticals Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Statistical analysis. 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 lpsen Biopharmaceuticals Inc. on December 23, 2022.
NDA 215559 is the application under which FDA issued this complete response letter for SOHONOS to lpsen Biopharmaceuticals Inc.. It was reviewed by FDA Other. The letter is dated December 23, 2022.
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.