FDA clears OTC use of Akorn's ketotifen fumarate

US drugmaker Akorn says that the Food and Drug Administration has granted approval for over-the-counter use of Akorn's Abbreviated New Drug Application for ketotifen fumarate ophthalmic solution, 0.025%.

Akorn's product is the generic equivalent of Swiss drug major Novartis' Zaditor ophthalmic solution 0.025%, which was recently granted OTC status by the FDA and Akorn will market this drug product on an OTC basis. It is indicated for up to 12 hours of temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. The brand product had annual sales of around $36.0 million in 2006, according to IMS Health sales data.