BOL , HITK ,,, Hi-Tech Pharmacal Gets Tentative FDA OK
Wednesday May 11, 7:06 pm ET
Hi-Tech Pharmacal Gets Tentative FDA OK for Generic Version of Floxin Ear Infection Treatment
AMITYVILLE, N.Y. (AP) -- Hi-Tech Pharmacal Co. said Wednesday that regulators tentatively approved its generic version of Floxin, an ear infection treatment made by Tokyo's Daiichi Pharmaceutical Co.
The Food and Drug Administration issues tentative approvals to generic drugs when the branded version is still covered by patent protections or retains exclusive selling rights, meaning Hi-Tech will not be able to sell its ofloxacin otic solution until those protections expire.
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However, Rochester, N.Y.-based Bausch & Lomb Inc. also has developed a generic version of Floxin and has sued Daiichi, charging that its patent is invalid. If a court rules in favor of Bausch & Lomb, Hi-Tech could begin selling its product about six months later, as Bausch & Lomb has exclusive selling rights to the generic for those first 180 days.
Daiichi's patent expires in 2012, Hi-Tech said. Floxin posted sales of $77 million in 2004.
Hi-Tech shares rose 53 cents, or 2.1 percent, to $25.93 in after-hours trading.
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