GANCICLOVIR SODIUM

Post-LOE

ganciclovir sodium

PharmaIN

ANDAINJECTIONINJECTABLE

Approved

Jun 2019

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

GANCICLOVIR SODIUM (ganciclovir sodium) by PharmaIN is [see microbiology ()] . Approved for cytomegalovirus (cmv) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (aids) [see clinical studies ()], cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies ()]. First approved in 2019.

Drug data last refreshed 21h ago

Mechanism of Action

[see Microbiology ()] .

Indications (1)

cytomegalovirus (CMV) retinitis in immunocompromised adult patients

Clinical Trials (1)

NCT00002034N/ACompleted

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

100 enrolled

Cytomegalovirus RetinitisHIV Infections

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.