For eosinophilic esophagitis (EoE). NDA 213976, held by Takeda Pharms USA. Budesonide.
As of Nov 13, 2026, NDA 213976 (Eohilia), held by Takeda Pharms USA, was first approved by FDA on Feb 9, 2024, with 1 approved supplement and 1 published complete response letter.
EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2024 | Original applicationNew dosage form · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 17, 2021 | Eohilia (budesonide oral suspension) | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eohilia2MG/10ML · suspension;oral | Budesonide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Feb 9, 2024 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
