August 4, 1998
CVM APPROVES FLUOROQUINOLONE PRODUCT FOR USE IN CATTLE
The Food and Drug Administration's Center for Veterinary Medicine has approved a new animal drug application for the use of enrofloxacin, which is a fluoroquinolone, in cattle for the treatment of bovine respiratory disease associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus sommus. The application, which was approved July 24, 1998, was submitted by Bayer Corporation.
The product, which has the trade name of Baytril 100 Injectable Solution, is restricted to use by or on the order of a licensed veterinarian. It is administered by injection and is intended to be used for the treatment of individual animals. The product is not for use in cattle intended for dairy production or in veal calves. Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. Extralabel use of fluoroquinolones in food animals has been prohibited by the FDA.
In an unprecedented initiative, Bayer has voluntarily committed to FDA to immediately take corrective action, up to and including stopping the sale of Baytril 100, should the FDA determine that continued use of the product in cattle presents a risk to public health and provides the company with the scientific evidence on which it based that conclusion. Bayer will be conducting an intensive monitoring program to assess if use of the product contributes to development of bacterial resistance to fluoroquinolones in cattle. Data collected from this program will be submitted regularly to the FDA for evaluation.
In addition to data collected by the firm, data on antimicrobial resistance is collected through the National Antimicrobial Resistance Monitoring System (NARMS) created in the U.S. in January 1996. This program is a collaboration among FDA, CDC, and USDA and monitors shifts in antimicrobial susceptibilities to 17 antimicrobials in zoonotic enteric organisms from both animal and human sources. The food animal specimens are gathered from healthy farm animals and from carcasses of food animals at slaughter. The NARMS was started (and has recently been expanded with resources from the Food Safety Initiative) because of the human health concerns related to the use of antimicrobials in food animals. By detecting resistance early, this system should help ensure the continued safety and efficacy of veterinary antimicrobials.
Post-approval monitoring for the development of bacterial resistance to fluoroquinolones is also being conducted by drug sponsors for other fluoroquinolones approved for use in food animals.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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