Issued to Armstrong Pharmaceuticals. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 22, 2014Application
NDA 505b1 • 205920
Product
PRIMATENE MIST
Company
Armstrong Pharmaceuticals
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, 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 Armstrong Pharmaceuticals on May 22, 2014.
NDA 205920 is the application under which FDA issued this complete response letter for PRIMATENE MIST to Armstrong Pharmaceuticals. It was reviewed by FDA Other. The letter is dated May 22, 2014.
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.