Treats itching associated with signs and symptoms of allergic conjunctivitis. NDA 22288, held by Bausch And Lomb Inc. Bepotastine Besilate.
As of Nov 13, 2026, NDA 22288 (Bepreve), held by Bausch And Lomb Inc, was first approved by FDA on Sep 8, 2009, with 3 approved supplements and 0 published complete response letters.
BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2009 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bepreve1.5% · solution/drops;ophthalmic | Bepotastine Besilate | RxReference drug |
| Feb 9, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Feb 5, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 28, 2012 | Supplement 3Labeling · Standard review | Approved | |
| Sep 8, 2009 | Original applicationNew molecular entity · 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
