NDAINTRAVENOUSSOLUTION
Approved
Feb 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
GANZYK-RTU (ganciclovir) by Bausch + Lomb is 12. First approved in 2017.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GANZYK-RTU is an intravenous antiviral solution containing ganciclovir, a nucleoside analogue with potent activity against cytomegalovirus (CMV). It is used to treat CMV infections, particularly in immunocompromised patients. Ganciclovir works by inhibiting viral DNA polymerase, preventing CMV replication.
Peak7.8 years to LOE
Product is at peak lifecycle stage with stable market presence; commercial teams are likely focused on maintaining market share and managing renal-impaired patient populations.
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 one 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…
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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.