Hi-Tech Sues FDA To Get Generic Cosopt Exclusivity

Law360 (September 4, 2008, 12:00 AM EDT) -- Hi-Tech Pharmacal Co. Inc. is asking a judge to force federal regulators to bar other generic-drug makers from the market for generic Cosopt until after the company has had 180 days of market exclusivity for the glaucoma drug.

In a motion filed Wednesday in the U.S. District Court for the District of Columbia, Hi-Tech says the U.S. Food and Drug Administration must be forced to withhold approval to other generics makers in order to preserve Hi-Tech's exclusivity rights under the Hatch-Waxman Act.

FDA plans to decide whether Hi-Tech is entitled to 180-day market exclusivity on Oct. 28, when it is expected...

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