Hi-Tech Granted Approval for Ofloxacin Otic Solution

March 19, 2008

Hi-Tech Pharmacal has announced that the FDA has granted final approval to the company’s abbreviated new drug application for ofloxacin otic solution, 0.3%.

Hi-Tech’s ofloxacin otic solution is the generic equivalent of Daiichi’s Floxin otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2007, had sales of $105 million according to IMS.