FAMCICLOVIR · NATCO PHARMA
Famciclovir is an antiviral medication indicated for the treatment of recurrent herpes labialis (cold sores), recurrent genital herpes, and herpes zoster (shingles) in immunocompetent adults. It is also used for chronic suppressive therapy of recurrent genital herpes and for treating recurrent orolabial or genital herpes in HIV-infected adults. **Limitations of Use:** Efficacy has not been established for the first episode of genital herpes, ophthalmic zoster, or for the suppression of recurrent genital herpes in Black and African American patients. Safety and efficacy for suppressive therapy beyond one year have not been established.
How FAMCICLOVIR Works
Famciclovir is a prodrug that is rapidly converted to the active antiviral agent penciclovir. As a deoxynucleoside analog, it is phosphorylated within viral-infected cells to penciclovir triphosphate. This active form inhibits **viral** DNA polymerase by competing with deoxyguanosine triphosphate, thereby terminating viral DNA chain elongation and inhibiting replication.
Details
- Status
- Discontinued
- First Approved
- 1994-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET
FAMCICLOVIR Approval History
What FAMCICLOVIR Treats
3 indicationsFAMCICLOVIR is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Labialis
- Genital Herpes
- Herpes Zoster
FAMCICLOVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07099157 | M20250600 | Ph 4 | recruiting | Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster |
| NCT00878072 results posted | CFAM810B2305 | Ph 2, Ph 3 | completed | Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis |
| NCT01281007 results posted | F125EMS1010 | Ph 3 | completed | Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes |
| NCT01526408 Famvir results posted | HRI-003 Meniere's Disease | Ph 3 | terminated | Famvir for Treatment of Hearing in Unilateral Meniere's Disease |
| NCT01327144 | F500EMS1010 | Ph 3 | completed | Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FAMCICLOVIR FDA Label Details
Indications & Usage
1 INDICATIONS & USAGE Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients • Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: • Patients with first epis...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.