Treats recurrent herpes labialis (cold sores). Sold as Denavir. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 14, 2026, FDA lists 5 applications for Penciclovir (sold as Denavir), first approved Sep 24, 1996, with 1 new use approved and 0 published complete response letters.
| Penciclovir | Part D | $3.3M | +1% | 3,809 |
| Denavir | Part D | $347K | -25% | 186 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled TrialAcute Pulmonary Embolism · University Hospital, Angers | Not applicable | Not yet recruiting | Apr 1, 2026 |
| Sep 24, 1996 | DenavirNDA 20629 · New molecular entity | Mylan | 8 | Marketed |
| Nov 9, 2022 | PenciclovirANDA 212710 | Teva Pharms USA | 0 | Marketed |
| Aug 7, 2023 | PenciclovirANDA 216981 | Torrent | 0 | Discontinued |
| Sep 27, 2024 | PenciclovirANDA 212368 | Padagis Israel | 0 | Marketed |
| Aug 22, 2025 | PenciclovirANDA 214100 | Amneal | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Mylan