DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Pre-Launchdolutegravir; lamivudine; tenofovir disoproxil fumarate
NDAORALTABLET
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (dolutegravir; lamivudine; tenofovir disoproxil fumarate) by Shanghai Sunway Biotech 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 (integrase inhibitor), lamivudine (nucleoside reverse transcriptase inhibitor), and tenofovir disoproxil fumarate (nucleotide reverse transcriptase inhibitor) for treating HIV-1 infection. The triple-agent regimen works by simultaneously blocking viral integration, reverse transcription, and nucleotide incorporation to suppress HIV replication. It is indicated for adults and pediatric patients weighing at least 6 kg with HIV-1 infection.
Pre-Launch
This product is in pre-launch phase with no commercial data available; team buildout and market planning strategy are currently being developed.
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.