NDAORAL SUSPENSIONTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
DOLUTEGRAVIR SODIUM (dolutegravir sodium) by Viatris (2) is fixed-dose combination of the hiv‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see microbiology ()]. Approved for human immunodeficiency virus infection.
Drug data last refreshed 2w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dolutegravir sodium is a fixed-dose combination oral tablet containing abacavir, dolutegravir, and lamivudine for the treatment of human immunodeficiency virus (HIV-1) infection. Dolutegravir is an integrase strand transfer inhibitor that blocks HIV replication by preventing viral DNA integration into the host genome. This combination represents a foundational antiretroviral regimen widely used in treatment-naïve and experienced patients.
Pre-Launch
Pre-launch stage indicates opportunities in brand development, market access, and launch planning teams at Viatris as regulatory approval approaches.
Mechanism of Action
fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology ()].
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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.