Overview
Famciclovir, marketed as Famvir by Novartis, is a guanine analogue used to treat herpes virus infections. It is most commonly used to treat herpes zoster (shingles). Famciclovir is a prodrug of penciclovir with higher oral bioavailability.
Indication
For the treatment of acute herpes zoster (shingles). Also for the treatment or suppression of recurrent genital herpes in immunocompetent patients and treatment of recurrent mucocutaneous herpes simplex infections in HIV infected patients.
Associated Conditions
- Herpes Zoster
- Recurrent Genital Herpes (RGH)
- Recurrent Herpes Labialis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/01 | Phase 2 | Not yet recruiting | |||
2024/04/25 | Phase 3 | Recruiting | |||
2023/10/23 | Phase 2 | Completed | |||
2023/09/13 | Phase 1 | Completed | |||
2022/03/17 | Phase 2 | UNKNOWN | |||
2021/09/17 | Phase 2 | Terminated | |||
2017/04/19 | Not Applicable | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2012/02/03 | Phase 3 | Terminated | |||
2011/04/01 | Phase 3 | Completed | EMS | ||
2011/03/23 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 17856-0708 | ORAL | 500 mg in 1 1 | 4/5/2021 | |
| Physicians Total Care, Inc. | 54868-5905 | ORAL | 500 mg in 1 1 | 12/22/2011 | |
| RPK Pharmaceuticals, Inc. | 53002-0640 | ORAL | 250 mg in 1 1 | 2/19/2021 | |
| Proficient Rx LP | 71205-609 | ORAL | 500 mg in 1 1 | 1/1/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-706 | ORAL | 125 mg in 1 1 | 2/19/2021 | |
| Rising Pharmaceuticals, Inc. | 64980-351 | ORAL | 500 mg in 1 1 | 7/31/2020 | |
| AvKARE | 42291-414 | ORAL | 125 mg in 1 1 | 1/9/2024 | |
| Apotex Corp. | 60505-3246 | ORAL | 250 mg in 1 1 | 12/14/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8117 | ORAL | 125 mg in 1 1 | 11/28/2022 | |
| Bryant Ranch Prepack | 63629-7890 | ORAL | 500 mg in 1 1 | 2/19/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FAMVIR TAB 250MG | N/A | N/A | N/A | 7/18/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FAMCICLO famciclovir 125 mg tablet blister pack | 266467 | Medicine | A | 2/24/2017 | |
| FAMVIR famciclovir 500mg tablets | 67391 | Medicine | A | 1/6/1999 | |
| APOTEX-FAMCICLOVIR famciclovir 500 mg tablet blister pack | 172444 | Medicine | A | 8/10/2011 | |
| PHARMACY ACTION COLD SORE ONCE famciclovir 500 mg tablet blister pack | 212558 | Medicine | A | 7/24/2013 | |
| FANTIVIR | 177009 | Medicine | A | 8/14/2012 | |
| FAMCICLOVIR- WGR 500 famciclovir 500 mg tablets blister pack | 425672 | Medicine | A | 1/12/2024 | |
| PRICELINE PHARMACY FAVIR FOR COLD SORES famciclovir 500 mg tablets blister pack | 378351 | Medicine | A | 11/19/2021 | |
| FAMCICLOVIR MYLAN famciclovir 500 mg tablet blister pack | 157787 | Medicine | A | 3/10/2010 | |
| FAMCICLOVIR GenPar famciclovir 125 mg tablet blister pack | 266471 | Medicine | A | 2/24/2017 | |
| FCICLOVIR famciclovir 125 mg tablet blister pack | 266481 | Medicine | A | 2/24/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APO-FAMCICLOVIR | 02292025 | Tablet - Oral | 125 MG | 2/22/2007 | |
| AVA-FAMCICLOVIR | avanstra inc | 02366843 | Tablet - Oral | 500 MG | 9/19/2011 |
| DOM-FAMCICLOVIR | dominion pharmacal | 02281929 | Tablet - Oral | 250 MG | N/A |
| FAMCICLOVIR | PRO DOC LIMITEE | 02324881 | Tablet - Oral | 500 MG | 10/16/2009 |
| NOVO-FAMCICLOVIR | novopharm limited | 02283948 | Tablet - Oral | 250 MG | N/A |
| PHL-FAMCICLOVIR | pharmel inc | 02281988 | Tablet - Oral | 500 MG | N/A |
| PMS-FAMCICLOVIR | 02278111 | Tablet - Oral | 500 MG | 11/17/2006 | |
| APO-FAMCICLOVIR | 02292068 | Tablet - Oral | 500 MG | 2/22/2007 | |
| DOM-FAMCICLOVIR | dominion pharmacal | 02281937 | Tablet - Oral | 500 MG | N/A |
| FAMCICLOVIR | Cobalt Pharmaceuticals Company | 02344785 | Tablet - Oral | 250 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FAMCICLOVIR NORMON 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 71964 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMCICLOVIR TECNIGEN 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 72490 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FAMVIR 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 60609 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| FAMCICLOVIR STADA 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 77136 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FAMVIR 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 65027 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| FAMCICLOVIR STADA 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 72495 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FAMCICLOVIR PENSA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 72009 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMCICLOVIR PENSA 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 72012 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMCICLOVIR TEVA 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 69340 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FAMVIR 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 61597 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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