Treats dry eye disease (DED). NDA 208073, held by Bausch And Lomb Inc. Lifitegrast.
As of Nov 13, 2026, NDA 208073 (Xiidra), held by Bausch And Lomb Inc, was first approved by FDA on Jul 11, 2016, with 3 approved supplements and 0 published complete response letters.
Xiidra (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xiidra5% · solution/drops;ophthalmic | Lifitegrast | RxReference drug |
| Apr 4, 2024 | Supplement 12Manufacturing | Approved | |
| Jun 4, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Dec 17, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Jul 11, 2016 | Original applicationNew molecular entity · Priority 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
