Manages osteoarthritis pain of the knee. NDA 208845, held by Pacira Pharms Inc. Triamcinolone Acetonide.
As of Nov 13, 2026, NDA 208845 (Zilretta), held by Pacira Pharms Inc, was first approved by FDA on Oct 6, 2017, with 4 approved supplements and 0 published complete response letters.
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
| Dec 23, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zilretta32MG/VIAL · for suspension, extended release;intra-articular | Triamcinolone Acetonide | RxReference drug |
| Dec 3, 2024 | Supplement 21Labeling · Standard review | Approved | |
| Sep 5, 2024 | Supplement 19Labeling · Standard review | Approved | |
| Dec 2, 2020 | Supplement 11Labeling · Standard review | Approved | |
| Dec 23, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 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
