Treats recurrent herpes labialis (cold sores). NDA 22436, held by Bausch. Acyclovir; Hydrocortisone.
As of Nov 14, 2026, NDA 22436 (Xerese), held by Bausch, was first approved by FDA on Jul 31, 2009, with 5 approved supplements and 0 published complete response letters.
XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).
| Jan 22, 2014 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jul 31, 2009 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xerese5%;1% · cream;topical | Acyclovir; Hydrocortisone | RxReference drug |
| Dec 11, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Apr 14, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 24, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 22, 2014 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| May 12, 2010 | Supplement 1Labeling | Approved | |
| Jul 31, 2009 | Original applicationNew combination · 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
