NDA 214900, held by Glaxosmithkline. Ibrexafungerp Citrate.
As of Nov 14, 2026, NDA 214900 (Brexafemme), held by Glaxosmithkline, was first approved by FDA on Jun 1, 2021, with 4 approved supplements and 0 published complete response letters.
| Nov 30, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jun 1, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BrexafemmeEQ 150MG BASE · tablet;oral | Ibrexafungerp Citrate | RxReference drug |
| Jul 24, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Nov 3, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Nov 30, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jun 15, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Jun 1, 2021 | Original applicationNew molecular entity · Priority 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
