Bayer Sues FDA Over Approval Of Generic Cattle Antibiotic

Law360, New York (April 11, 2013, 1:37 PM EDT) -- Bayer AG on Wednesday sued the U.S. Food and Drug Administration in Washington federal court over the agency's recent approval of a generic version of cattle medication Baytril 100, saying the cloned product will inevitably be used in an off-label manner that violates a company patent.

The complaint targets a Baytril knockoff marketed by U.K.-based Norbrook Laboratories Ltd., which last month won clearance for bovine respiratory disease antibiotic Enroflox 100, but only for multidose treatment, not the single-dose application covered by Bayer's U.S. Patent Number 5,756,506,...
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