Treats neurotrophic keratitis. BLA 761094, held by Dompe Farmaceutici. Cenegermin-Bkbj.
As of Nov 14, 2026, BLA 761094 (Oxervate), held by Dompe Farmaceutici, was first approved by FDA on Aug 22, 2018, with 3 approved supplements and 0 published complete response letters.
OXERVATE (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxervate0.002%(20MCG/ML) · solution;ophthalmic | Cenegermin-Bkbj | Rx |
| Oct 20, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Oct 20, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Oct 30, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Aug 22, 2018 | 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
