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U.S. Department of Health and Human Services

Animal & Veterinary

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Extra-Label Use of Baytril 100 Prohibited, Including Use in Dairy Cattle or Veal Calves

September 22, 1998

In the Federal Register of September 14, 1998, FDA’s Center for Veterinary Medicine announced the approval of a new animal drug application for the use of a fluoroquinolone product, enrofloxacin. This product, trade name Baytril 100 Injectable Solution, is approved for use by prescription only in cattle and only for the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus. Any extralabel use of fluoroquinolones, including Baytril 100, in food animals is prohibited under Title 21, Part 530.41, of the Code of Federal Regulations.

Baytril 100 is not approved for use in those cattle intended for dairy production or calves to be processed for veal. The term "cattle intended for dairy production" refers to all classes of cattle involved in the dairy farm operation including calves reared as dairy cow replacements, heifers, lactating and non-lactating (dry) dairy cows, and bulls maintained for breeding purposes. Baytril 100 may be used to treat BRD only in dairy breed animals (e.g., dairy breed feedlot steers, bulls, heifers) maintained for beef production.

The restriction on use of Baytril 100 in cattle intended for dairy production and calves to be processed for veal is based on human food safety concerns. These concerns include the increased prevalence of certain pathogens with zoonotic potential (such as Salmonella) on dairy farms, the higher level of human-animal contact on dairies, and concerns about meat and milk safety.

Because of these human food safety concerns, Baytril 100 should not be used to treat cattle intended for dairy production or stored in dairy farm drug cabinets. FDA Regional Milk Specialists will be looking for the presence of the drug during dairy farm inspections conducted under the Grade A Pasteurized Milk Ordinance. Causing the use or using this drug in cattle intended for dairy production or calves to be processed for veal may result in regulatory action by FDA and/or State regulatory authorities.

Baytril 100 should be used only in the appropriate classes of cattle when BRD is diagnosed. Veterinarians should be particularly prudent in the selection of therapy for BRD (as for any disease) when concurrent diseases are present. Concurrent disease, such as enteric disease, is of concern because it may be associated with organisms that may be transferred to humans.

Further information about the approval of Baytril 100 is contained in the September 14, 1998, Federal Register document (pp. 49002-49003). Any questions concerning the restrictions on the use of Baytril 100 may be directed to Dr. Michael Talley on (215) 597-4390 ext. 4541#. Please note, the number (#) sign must be entered.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855