VALGANCICLOVIR HYDROCHLORIDE

Post-LOE

valganciclovir hydrochloride

Lavipharm

ANDAORALTABLET

Approved

Mar 2021

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

VALGANCICLOVIR HYDROCHLORIDE (valganciclovir hydrochloride) by Lavipharm is [see microbiology ()] . Approved for cmv disease in kidney transplant patients (4 months to 16 years of age), heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies ()]. First approved in 2021.

Drug data last refreshed 1w ago

Mechanism of Action

[see Microbiology ()] .

Indications (1)

CMV disease in kidney transplant patients (4 months to 16 years of age)

Clinical Trials (2)

NCT02297854Phase 1Completed

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

Started Jul 2011

83 enrolled

Healthy

NCT02296723Phase 1Completed

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

Started Jul 2011

66 enrolled

Healthy

Company

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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.