Issued to Pharmaxis Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 18, 2013Application
NDA 505b1 • 202049
Product
BRONCHITOL
Company
Pharmaxis Ltd.
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, 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 Pharmaxis Ltd. on March 18, 2013.
NDA 202049 is the application under which FDA issued this complete response letter for BRONCHITOL to Pharmaxis Ltd.. It was reviewed by FDA Other. The letter is dated March 18, 2013.
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.