NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE (lamivudine; zidovudine; nevirapine) by Cipla 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
A fixed-dose combination tablet of three HIV-1 antiretroviral agents: lamivudine (nucleoside reverse transcriptase inhibitor), zidovudine (nucleoside reverse transcriptase inhibitor), and nevirapine (non-nucleoside reverse transcriptase inhibitor). This oral combination therapy is indicated for HIV-1 infection in adults and pediatric patients weighing at least 6 kg, working synergistically to suppress viral replication.
Pre-Launch
This pre-launch product represents an opportunity for early commercial build-out; team size and budget allocation will depend on Cipla's go-to-market strategy and competitive positioning in the fixed-dose combination HIV space.
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.