Enroflox 100 approved for single dose

FDA approves Enroflox 100 (enrofloxacin) Injectable single-dose treatment and control of BRD in cattle.

Norbrook Laboratories Ltd. announced the Food & Drug Administration approval of Enroflox 100 (enrofloxacin) for the single-dose treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Norbrook, a global veterinary pharmaceutical company, said the BRD treatment and control antibiotic has the same active ingredient, formulation and dosing regimen as Baytril 100 (enrofloxacin). With this approval, Enroflox 100 is now labeled as an effective and proven single-dose treatment and control option for the major pathogens of BRD in cattle and non-lactating heifers less than 20 months of age and for multi-day use for BRD treatment.

Enroflox 100 is available from veterinarians in 100 mL and 250 mL bottles to fit any size operation. For more information about new Enroflox 100, contact your veterinarian, local animal health products supplier or Norbrook, Inc. at www.norbrookinc.com.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or calves born to these cows. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. Use with caution in animals with known or suspected CNS disorders. Observe label directions and withdrawal times. See product labeling for full product information.

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