Issued to Cyclomedica Australia Pty Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 25, 2021Application
NDA 505b1 • 022335
Product
TECHNEGAS KIT
Company
Cyclomedica Australia Pty Ltd.
Review center
Other
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Safety and adverse events, Facility inspection and CGMP compliance. 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 Cyclomedica Australia Pty Ltd. on June 25, 2021.
NDA 022335 is the application under which FDA issued this complete response letter for TECHNEGAS KIT to Cyclomedica Australia Pty Ltd.. It was reviewed by FDA Other. The letter is dated June 25, 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.