Issued to APOTEX INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
March 20, 2026Application
ANDA 505j • 218575
Product
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Company
APOTEX INC
Stage
Final Decision
Assyro regulatory brief
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FDA issued a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Not for marketing yet. FDA granted tentative approval to ANDA 218575 for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on March 20, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
ANDA 218575 is the application under which FDA issued this tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE to APOTEX INC. The letter is dated March 20, 2026.
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.