NDAORALTABLET, FOR SUSPENSIONPriority Review
Lifecycle
Pre-Launch
Data completeness
2/8 — Basic
Priority Review
ABACAVIR SULFATE; LAMIVUDINE (abacavir sulfate; lamivudine) 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
Abacavir sulfate and lamivudine is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTIs) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 6 kg. The combination works by inhibiting reverse transcriptase, blocking HIV-1 replication. This oral tablet formulation simplifies regimen adherence in antiretroviral-naive and treatment-experienced patients.
Pre-Launch
Product is pre-launch with no established market presence; early-stage commercial team building and market access strategy development will be critical.
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.