Treats pain and inflammation associated with cataract surgery. NDA 21862, held by Harrow Eye. Nepafenac.
As of Nov 15, 2026, NDA 21862 (Nevanac), held by Harrow Eye, was first approved by FDA on Aug 19, 2005, with 5 approved supplements and 0 published complete response letters.
NEVANAC 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2005 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevanac0.1% · suspension/drops;ophthalmic | Nepafenac | RxReference drug |
| Nov 4, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Dec 15, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Mar 7, 2014 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jun 27, 2011 | Supplement 8Labeling | Approved | |
| May 8, 2008 | Supplement 2Labeling · Standard review | Approved | |
| Aug 19, 2005 | 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
