Drugs / Famciclovir
Famciclovir
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | FAMVIR | — | 1995-12-11 – 2012-02-09 | fda.gov ↗ |
| Approved | US (FDA) | FAMVIR | — | 1994-06-29 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00834444 | Aug → Sep 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00834431 | Aug → Sep 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05283551 | Nov 2020 → Nov 2023 | multiple sclerosis | Queen Mary University of London | Unknown | Missed primary |
| Phase 2 | NCT00448227 | Oct 2007 → Nov 2008 | herpes simplex infectious disease | Novartis | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00878072 | Mar 2009 → Jun 2010 | herpes labialis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT01281007 | Jul 2012 → Jan 2015 | genital herpes | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01327144 | Jun 2012 → May 2017 | herpes zoster | EMS | Completed | Met primary |
| Phase 3 | NCT00306787 | Mar 2006 → Feb 2008 | genital herpes | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00098046 | Jul 2005 → Jul 2007 | chickenpox, herpes zoster | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00098059 | Feb 2005 → Dec 2007 | herpes simplex infectious disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00171990 | Jan 2003 → Feb 2006 | genital herpes | Novartis | Completed | No outcome recorded |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT00477334 | Jun 2007 → Mar 2009 | genital herpes | Novartis | Completed | Missed primary |
| Phase 4 | NCT00129818 | Jul 2004 → Oct 2005 | genital herpes | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00248144 | Oct 2003 → Jul 2007 | herpes labialis | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00219310 | Jun 2003 → Jun 2005 | genital herpes | Novartis | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01526408 Comparator | Dec 2011 → Jan 2015 | Meniere disease | House Research Institute | Terminated | No outcome recorded |
| Phase 4 | NCT07099157 Comparator | Aug 2025 → Dec 2026 expected | herpes zoster | Peking University Third Hospital | Recruiting | No outcome recorded |
| — | NCT06798662 Background | Feb → Jun 2025 overdue | herpes zoster | Xiaguang Duan | Not yet recruiting | No outcome recorded |
| — | NCT03120962 Background | May 2017 → May 2020 | herpes zoster, postherpetic neuralgia | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2007-08-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Generic Famvir® Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Famvir® (Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. |
| 2007-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Famciclovir Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Famciclovir Tablets, 125 mg, 250 mg and 500 mg. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-02-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Agreement on Famvir® Patent Challenge tevapharm.com ↗ |
| 2007-09-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Court Of Appeals Denies Novartis' Emergency Motion On Generic Famvir® tevapharm.com ↗ |
| 2007-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update On Generic Famvir® Litigation tevapharm.com ↗ |
| 2007-09-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch Of Generic Famvir® Tablets tevapharm.com ↗ |
| 2007-09-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Favorable Court Decision Regarding Generic Famvir® Tablets tevapharm.com ↗ |
| 2007-08-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Generic Famvir® Tablets tevapharm.com ↗ |
| 2007-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Famciclovir Tablets tevapharm.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Famciclovir | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗ |
| Known as | BRL-42810 | ChEMBL registry synonym — accepted as the source's own label CHEMBL880 ↗ |
| Known as | Famvir | ChEMBL registry synonym — accepted as the source's own label CHEMBL880 ↗ |
| Known as | NSC-758921 | ChEMBL registry synonym — accepted as the source's own label CHEMBL880 ↗ |
| Modality | Small molecule | — CHEMBL880 ↗ |
| Route | Oral | “pediatric oral famciclovir formulation” PMID 19273678 ↗ Mar 2009 |