Issued to Mylan Pharmaceuticals Inc., a Viatris Company. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 13, 2023Application
NDA 505b1 • 204311
Product
ABACAVIR SULFATE AND LAMIVUDINE
Company
Mylan Pharmaceuticals Inc., a Viatris Company
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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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 Mylan Pharmaceuticals Inc., a Viatris Company on January 13, 2023.
NDA 204311 is the application under which FDA issued this complete response letter for ABACAVIR SULFATE AND LAMIVUDINE to Mylan Pharmaceuticals Inc., a Viatris Company. It was reviewed by FDA Other. The letter is dated January 13, 2023.
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.