NDA 202872, held by Bausch And Lomb Inc. Loteprednol Etabonate.
As of Nov 13, 2026, NDA 202872 (Lotemax), held by Bausch And Lomb Inc, was first approved by FDA on Sep 28, 2012, with 1 approved supplement and 0 published complete response letters.
LOTEMAX (loteprednol etabonate ophthalmic gel) 0.5% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. LOTEMAX is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
| Jul 20, 2018 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotemax0.5% · gel;ophthalmic | Loteprednol Etabonate | RxReference drug |
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
