DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Pre-Launchdolutegravir; lamivudine; tenofovir disoproxil fumarate
NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
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 oral tablet containing dolutegravir, lamivudine, and tenofovir disoproxil fumarate for treatment of HIV-1 infection. The combination employs an integrase inhibitor (dolutegravir) plus two nucleoside reverse transcriptase inhibitors to suppress viral replication. It is indicated for HIV-1 infected adults and patients weighing at least 6 kg.
Pre-Launch
As a pre-launch asset, this product presents a greenfield commercial opportunity with significant team-building and market-entry planning underway; expect sustained focus on launch readiness and physician/payer engagement.
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.