Treats molluscum contagiosum (MC). NDA 217424, held by Lnhc. Berdazimer Sodium.
As of Nov 13, 2026, NDA 217424 (Zelsuvmi), held by Lnhc, was first approved by FDA on Jan 5, 2024, with 0 approved supplements and 0 published complete response letters.
ZELSUVMI is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZelsuvmiEQ 10.3% BASE · gel;topical | Berdazimer Sodium | RxReference drug |
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
