DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Pre-Launchdolutegravir; lamivudine; tenofovir disoproxil fumarate
NDAORALTABLET
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
DOLUTEGRAVIR, LAMIVUDINE AND 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 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
A fixed-dose combination antiretroviral tablet containing dolutegravir, lamivudine, and tenofovir disoproxil fumarate for treating HIV-1 infection. This oral combination integrates an integrase strand transfer inhibitor (dolutegravir) with two nucleoside reverse transcriptase inhibitors to provide comprehensive viral suppression. The product targets adults and pediatric patients weighing at least 6 kg.
Pre-Launch
Early-stage asset in regulatory review with no commercial data yet; successful launch could establish a significant team for a core HIV indication.
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.