October 15, 2005

 

 Bayer pulls Baytril - October 15, 2005

 

posted October 1, 2005

Ending a five-year battle with the Food and Drug Administration, Bayer Corporation has stopped distribution of the antimicrobial enrofloxacin for poultry, which was marketed under the name Baytril 3.23% Concentrate Antimicrobial Solution.

On July 28, the FDA announced it would no longer allow distribution or use of enrofloxacin after judging that it causes resistance in Campylobacter jejuni when used to treat respiratory infections in poultry (see JAVMA, Sept. 1, 2005). The final rule stated Bayer could appeal the withdrawal to a U.S. Court of Appeals within 60 days.

In response, Bayer, the Animal Health Institute, and various other groups requested that the FDA issue a delay of the ban to allow certain poultry industry organizations more time to consider alternative medicines, according to Bayer spokesperson Bob Walker. The FDA denied the request.

The FDA's decision to deny the request led Bayer to rethink its position and the possibility of being successful in a court, Walker said, leading the company to comply with the ban.