FDA approves Hi-Tech's generic Floxin

WASHINGTON The Food and Drug Administration has granted approval to Hi-Tech Pharmacal for its application for ofloxacin otic solution, 0.3 percent.

The drug, which is a generic version of Daiichi Sankyo’s Floxin otic solution, is used to treat bacterial infections of the ear.

Daiichi Sankyo had tried to validate its patent in courts last July, but lost the appeals court ruling, which opened the market up for generic competition.

Floxin had sales of $105 million in 2007, according to IMS Health.