NDAINJECTIONINJECTABLEPriority Review
Approved
Jun 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
CYTOVENE (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 ()] and 3 more indications. First approved in 1989.
Drug data last refreshed 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTOVENE (ganciclovir sodium) is an intravenous antiviral agent approved in 1989 for treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and CMV disease prevention in transplant recipients. It works through viral DNA synthesis inhibition via phosphorylation and incorporation into viral DNA. The drug targets high-risk populations including AIDS patients and organ transplant recipients vulnerable to CMV complications.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting transition to defensive strategy and potential team downsizing or reallocation.
Mechanism of Action
[see Microbiology ()] .
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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.