NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
STAVUDINE; LAMIVUDINE; NEVIRAPINE (stavudine; lamivudine; nevirapine) by PharmaIN is 12. Approved for human immunodeficiency virus (hiv)-1 infection [see ].
Drug data last refreshed 5h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
This is a fixed-dose combination of three antiretroviral agents (stavudine, lamivudine, and nevirapine) for treatment of HIV-1 infection. The combination leverages nucleoside reverse transcriptase inhibitors (stavudine and lamivudine) and a non-nucleoside reverse transcriptase inhibitor (nevirapine) to suppress viral replication. The product is administered orally as a tablet and targets adult and pediatric HIV-1-infected populations.
Post-LOE
This pre-launch fixed-dose combination faces a highly commoditized HIV treatment landscape with minimal growth prospects and limited commercial resources allocated.
Mechanism of Action
12.1 Mechanism of Action Stavudine is an antiviral drug [see ]. 12.3 Pharmacokinetics The pharmacokinetics of stavudine have been evaluated in HIV-1-infected adult and pediatric patients (, , and ). Peak plasma concentrations (C max ) and area under the plasma concentration-time curve (AUC)…
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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.