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 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cytovene (ganciclovir sodium) is an injectable antiviral medication used to treat cytomegalovirus (CMV) infections in immunocompromised patients, particularly those with AIDS-related CMV retinitis and transplant recipients. It works by inhibiting CMV viral DNA synthesis through incorporation into viral DNA and chain termination. The drug has been a cornerstone therapy for CMV disease management since its approval in 1989.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting a mature brand with declining team investment and limited growth opportunities.
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.