Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets
Pre-Launchlamivudine; zidovudine; nevirapine
NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets (lamivudine; zidovudine; nevirapine) by PharmaIN 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 co-packaging lamivudine 150 mg, zidovudine 300 mg, and nevirapine 200 mg for oral administration. This product treats HIV-1 infection in adults and patients weighing at least 6 kg by combining three nucleoside/non-nucleoside reverse transcriptase inhibitors. The combination works by inhibiting HIV-1 reverse transcriptase through complementary mechanisms to suppress viral replication.
Pre-Launch
Product is in pre-launch phase with no established market presence; commercial team building and market entry planning are underway.
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.