NDA 208562, held by Hikma. Voriconazole.
As of Nov 13, 2026, NDA 208562 (Voriconazole), held by Hikma, was first approved by FDA on Mar 9, 2017, with 5 approved supplements and 0 published complete response letters.
Voriconazole for injection is an azole antifungal indicated for use in the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: Invasive aspergillosis Candidemia in non-neutropenics and other deep tissue Candida infections Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Voriconazole200MG/VIAL · powder;intravenous | Voriconazole | Rx |
| Voriconazole200MG · injectable;injection | Voriconazole | Rx |
| Apr 18, 2025 | Supplement 11Labeling · Standard review | Approved | |
| Jan 3, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Aug 16, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Dec 17, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Mar 26, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Mar 9, 2017 | Original applicationNew formulation or manufacturer · 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
