NDAORALTABLET
Lifecycle
Pre-Launch
Clinical Trials
1
Data completeness
3/8 — Basic
LAMIVUDINE, NEVIRAPINE, AND STAVUDINE (lamivudine; nevirapine; stavudine) by Hetero 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 lamivudine, nevirapine, and stavudine for the treatment of HIV-1 infection in adults and children weighing at least 6 kg. The product combines nucleoside reverse transcriptase inhibitors (lamivudine and stavudine) with a non-nucleoside reverse transcriptase inhibitor (nevirapine) to suppress viral replication. This triple-agent regimen represents a traditional antiretroviral approach for resource-limited settings and developing markets.
Pre-Launch
Pre-launch stage indicates emerging opportunity for launch teams; limited commercial visibility suggests smaller initial team footprint with potential expansion post-approval.
Mechanism of Action
fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology ()].
Indications (2)
Clinical Trials (1)
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
Started Dec 2006
44 enrolled
HIV Infections
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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.