DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
Pre-Launchdolutegravir; lamivudine; tenofovir disoproxil fumarate
NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (dolutegravir; lamivudine; tenofovir disoproxil fumarate) by Viatris (2) is fixed-dose combination of the hiv‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see microbiology ()]. Approved for hiv-1 infection in adults, weighing at least 6 kg.
Drug data last refreshed 2w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
This is a fixed-dose combination tablet containing dolutegravir (an integrase strand transfer inhibitor), lamivudine (a nucleoside reverse transcriptase inhibitor), and tenofovir disoproxil fumarate (a nucleotide reverse transcriptase inhibitor) for treating HIV-1 infection. The combination works synergistically by blocking viral replication through multiple mechanisms of action. It is indicated for HIV-1 infected adults and pediatric patients weighing at least 6 kg.
Pre-Launch
Pre-launch stage indicates significant opportunity for launch planning, market access, and commercial infrastructure development with potential for sizable team expansion.
Mechanism of Action
fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology ()].
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.