Issued to AB Pharmaceuticals, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 12, 2018Application
NDA 505b1 • 210649
Product
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Company
AB Pharmaceuticals, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 AB Pharmaceuticals, LLC on September 12, 2018.
NDA 210649 is the application under which FDA issued this complete response letter for EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE to AB Pharmaceuticals, LLC. It was reviewed by FDA Other. The letter is dated September 12, 2018.
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.