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 12h 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)

NCT00014014Phase 1Completed

Zidovudine and Lamivudine Given Once Versus Twice Daily

20 enrolled

HIV Infections

NCT00000841Phase 3Completed

A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

1,750 enrolled

HIV Infections

NCT00000878Phase 1Completed

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

26 enrolled

HIV InfectionsPregnancy

NCT00002190Phase 2Completed

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

30 enrolled

HIV Infections

NCT00002451Phase 2Unknown

Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

8 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.