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 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
This is a fixed-dose combination tablet containing abacavir, dolutegravir, and lamivudine for oral treatment of HIV-1 infection in adults and pediatric patients weighing at least 6 kg. It combines a nucleoside reverse transcriptase inhibitor (abacavir, lamivudine) with an integrase strand transfer inhibitor (dolutegravir) to suppress HIV replication through multiple mechanisms. The product is in pre-launch stage under Aurobindo Pharma's development.
Pre-Launch
Early-stage launch opportunity with limited current commercial data; team growth will depend on regulatory approval and market penetration strategy.
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.