Issued to Omeros Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 15, 2021Application
BLA • 761152
Product
YARTEMLEA
Company
Omeros Corporation
Stage
Final Decision
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, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Omeros Corporation on October 15, 2021.
BLA 761152 is the application under which FDA issued this complete response letter for YARTEMLEA to Omeros Corporation. The letter is dated October 15, 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.