GANCICLOVIR SODIUM

Post-LOE

ganciclovir sodium

PharmaIN

ANDAINJECTIONINJECTABLE

Approved

Dec 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

GANCICLOVIR SODIUM (ganciclovir sodium) by PharmaIN is 12. Approved for cytomegalovirus (cmv) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (aids) [see )], cmv disease in adult transplant recipients at risk for cmv disease [see ]. First approved in 2017.

Drug data last refreshed 18h ago

Mechanism of Action

12.1 Mechanism of Action Ganciclovir is an antiviral drug with activity against CMV [see ] . 12.3 Pharmacokinetics Absorption At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ± 3.2 (n=16) and 26.8 ± 6.1 mcg∙hr/mL (n=16) and C max ranged between 8.27…

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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.

GANCICLOVIR SODIUM

Mechanism of Action

Indications (1)

Clinical Trials (1)