Issued to Therakind Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 22, 2021Application
NDA 505b1 • 212479
Product
JYLAMVO
Company
Therakind Limited
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, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, Safety and adverse events. 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 Therakind Limited on December 22, 2021.
NDA 212479 is the application under which FDA issued this complete response letter for JYLAMVO to Therakind Limited. It was reviewed by FDA Other. The letter is dated December 22, 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.