LAMIVUDINE

Post-LOE

lamivudine

Signatur Biosciences

ANDAORALTABLET

Approved

Dec 2014

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

LAMIVUDINE (lamivudine) by Signatur Biosciences is nucleoside reverse transcriptase inhibitors [moa]. Approved for hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2014.

Drug data last refreshed 9h ago

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Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Pharmacologic Class:

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT00002190Phase 2Completed

A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

30 enrolled

HIV Infections

NCT00000887Phase 1Completed

A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

24 enrolled

HIV InfectionsPregnancy

NCT00710216Phase 4Withdrawn

Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

40 enrolled

Hepatitis B, Chronic

NCT00002179Phase 4Completed

The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection

200 enrolled

HIV Infections

NCT00042393N/AApproved For Marketing

An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options

Chronic Hepatitis B

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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.