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.
“FDA itself acknowledges that its action has not been regular; it failed to respond to the citizen petition for years and failed to provide a reasoned basis for rejecting it before approving Enroflox,” U.S. District Judge Rosemary Collyer said in an opinion made public today.
The FDA approved Norbrook’s application for Enroflox on March 29. Norbrook, based in the U.K., sought FDA approval in 2008 to market a generic version of Baytril 100 that would be labeled as a multiday dosing regimen.
Bayer sued the FDA on April 10, alleging it told the agency in 2006 that the generic version of its product will be used in a single dose.
Jalil Isa, an FDA spokesman, declined to comment on the matter. A woman who answered the phone at Norbrook’s U.S. office in Lenexa, Kansas, and wouldn’t identify herself, said the company would have no comment on the case.
The case is Bayer Healthcare LLC v. U.S. Food and Drug Administration, 13-cv-00487, U.S. District Court, District of Columbia (Washington).