Relieves itchy eyes due to ragweed, pollen, grass, animal hair and dander. NDA 21996, held by Bausch And Lomb. Ketotifen Fumarate.
As of Nov 14, 2026, NDA 21996 (Alaway, Children'S Alaway), held by Bausch And Lomb, was first approved by FDA on Dec 1, 2006, with 4 approved supplements and 0 published complete response letters.
Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| AlawayEQ 0.025% BASE · solution/drops;ophthalmic | Ketotifen Fumarate | OTCReference drug |
| Children'S AlawayEQ 0.025% BASE · solution/drops;ophthalmic | Ketotifen Fumarate | OTCReference drug |
| Apr 14, 2021 | Supplement 17Labeling · Standard review | Approved | |
| Feb 11, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 11, 2015 | Supplement 8Labeling · Standard review | Approved | |
| Apr 18, 2007 | Supplement 1Manufacturing | Approved | |
| Dec 1, 2006 | Original applicationNew formulation or manufacturer · 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
