NDA 221154, held by Aicuris Anti-Infect. Pritelivir Mesylate.
As of Nov 14, 2026, NDA 221154 (Hovilpri), held by Aicuris Anti-Infect, was first approved by FDA on Oct 9, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| HovilpriEQ 100MG BASE · tablet;oral | Pritelivir Mesylate | 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
