Norbrook Laboratories Ltd. announced that following the Food & Drug Administration's denial of a citizen petition filed by Bayer Animal Health, FDA has re-instated in full its prior approval of the sale and use of Norbrook's new Enroflox 100 (enrofloxacin) in cattle and non-lactating dairy heifers less than 20 months of age. New Enroflox 100 is approved for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somnus in beef and non-lactating dairy cattle.
Norbrook, a global veterinary pharmaceutical company, said the new BRD treatment antibiotic has the same active ingredient and formulation as Baytril 100 (enrofloxacin) and is approved in cattle for multi-day use only.
Enroflox 100 will be available from veterinarians in 100 mL and 250 mL bottles to fit any size operation.
For use by or on the order of a licensed veterinarian. Enroflox 100 is not approved for a one-day, single dose of therapy in cattle. 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.