July 27, 2007
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Akorn receives FDA clearance for over-the-counter topical ocular allergy drug
BUFFALO GROVE, Ill. Akorn has received U.S. Food and Drug Administration approval to market ketotifen fumarate ophthalmic solution 0.025% for over-the-counter use, Akorn announced in a press release.
The drug is a generic equivalent of Novartis' Zaditor ophthalmic solution 0.025%, which was recently granted over-the-counter status. It is indicated for up to 12 hours of temporary relief for itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Akorn expects to launch the product in October, according to the release.