Issued to Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 28, 2025Application
NDA 505b1 • 205508
Product
ATAZANAVIR SULFATE; RITONAVIR
Company
Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.
Review center
CDERStage
Final Decision
Response due
July 28, 2026
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, Bioequivalence and pharmacokinetics. 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 Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. on July 28, 2025.
NDA 205508 is the application under which FDA issued this complete response letter for ATAZANAVIR SULFATE; RITONAVIR to Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.. It was reviewed by FDA CDER. The letter is dated July 28, 2025.
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.