Issued to ASPEN SA OPERATIONS (PTY) LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
May 5, 2026Application
NDA 505b1 • 219804
Product
DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE
Company
ASPEN SA OPERATIONS (PTY) LTD
Stage
Final Decision
Assyro regulatory brief
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FDA issued a tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on 2026-05-05. The source metadata identifies NDA 219804 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 NDA 219804 for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on May 5, 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.
NDA 219804 is the application under which FDA issued this tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE to ASPEN SA OPERATIONS (PTY) LTD. The letter is dated May 5, 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.