NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE (abacavir; dolutegravir; lamivudine) by Aurobindo Pharma 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 2h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
This is a fixed-dose oral combination tablet containing abacavir, dolutegravir, and lamivudine for treatment of HIV-1 infection in adults and children weighing at least 6 kg. It combines a nucleoside reverse transcriptase inhibitor (abacavir and lamivudine) with an integrase strand transfer inhibitor (dolutegravir) to provide comprehensive antiretroviral therapy. The three-in-one formulation simplifies dosing and improves medication adherence.
Pre-Launch
Pre-launch stage indicates rapid team expansion in regulatory, commercial operations, and market access roles ahead of product introduction.
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.