Treats recurrent herpes labialis (cold sores). NDA 20629, held by Mylan. Penciclovir.
As of Nov 13, 2026, NDA 20629 (Denavir), held by Mylan, was first approved by FDA on Sep 24, 1996, with 8 approved supplements and 0 published complete response letters.
DENAVIR is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.
| Oct 10, 2003 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 1996 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Denavir1% · cream;topical | Penciclovir | RxReference drug |
| Nov 21, 2018 | Supplement 19Labeling · Standard review | Approved | |
| Feb 9, 2015 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 11, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Oct 10, 2003 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Aug 18, 2001 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1996 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
