NDA 218709, held by X4 Pharms. Mavorixafor.
As of Nov 13, 2026, NDA 218709 (Xolremdi), held by X4 Pharms, was first approved by FDA on Apr 26, 2024, with 0 approved supplements and 0 published complete response letters.
XOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lympocytes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xolremdi100MG · capsule;oral | Mavorixafor | 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
