Treats macular edema associated with uveitis. NDA 211950, held by Bausch And Lomb Inc. Triamcinolone Acetonide.
As of Nov 15, 2026, NDA 211950 (Xipere), held by Bausch And Lomb Inc, was first approved by FDA on Oct 22, 2021, with 1 approved supplement and 1 published complete response letter.
XIPERE (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for the treatment of macular edema associated with uveitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2021 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 18, 2019 | XIPERE (triamcinolone acetonide ophthalmic suspension) | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xipere40MG/ML · suspension;injection | Triamcinolone Acetonide | RxReference drug |
| May 22, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Oct 22, 2021 | Original applicationNew dosage form · 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
