The FDA Center for Veterinary Medicine has granted Bayer Animal Health a conditional approval for Baytril 100-CA1 (enrofloxacin) Injectable Solution for the treatment of clinical anaplasmosis in cattle. The product will be available to veterinarians and cattle producers in May 2020.
“This conditional approval allows us to offer the proven efficacy of enrofloxacin as a new treatment for this potentially deadly disease,” said Sebastian Kuszmierczyk, head of farm animal products in the US for Bayer Animal Health.
Until now, tetracycline antimicrobials, oxytetracycline injectables or chlortetracycline medicated feed were the only drugs used in the US for treatment of acute anaplasmosis.
Baytril 100-CA1 contains the proven molecule enrofloxacin, and is indicated for the treatment of clinical anaplasmosis associated with Anaplasma marginalein all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding of any age.
Baytril 100-CA1 is conditionally approved pending a full demonstration of effectiveness. Baytril 100-CA1 has a reasonable expectation of effectiveness for treatment of clinical anaplasmosis in the conditionally approved classes of cattle, when it is administered for the conditionally approved dosage regimen based on published scientific literature and reports from studies conducted by the sponsor. Enrofloxacin treatment in cattle infected with A. marginale resulted in a decrease in parasitemia and, when evaluated, improvement in clinical variables (hematocrit and rectal temperatures), Bayer says.
Enrofloxacin has been shown to have no adverse effects on cow reproductive performance, pregnancy and lactation, and no effect on calf viability and health.
Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. The effects of enrofloxacin on bull reproductive performance have not been adequately determined. Federal (U.S.A.) law prohibits the extra-label use of this drug in food-producing animals.
For information about Baytril 100-CA1, or to obtain a product label call Bayer Veterinary Services at 1-800-422-9874 or visit www.BayerLivestock.com.
Source: Bayer Animal Health, which is solely responsible for the information provided and is wholly owned by the source. Informa Business Media and all its subsidiaries are not responsible for any of the content contained in this information asset.