Bayer Wins Bid to Block Norbrook Sale of Generic Baytril
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Bayer AG won an agreement from the U.S. Food and Drug Administration to block sales of a generic version of its livestock antibiotic Baytril 100 made by Norbrook Laboratories Ltd.
The FDA on April 19 agreed to withhold its approval of Norbrook’s Enroflox 100 product to treat bovine respiratory disease. The decision came two days after a federal judge in Washington ruled that the agency offered no evidence it gave any consideration to Leverkusen, Germany-based Bayer’s concerns the generic would be used for a so-called off-label dosage.