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 marginale all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding of any age and in replacement dairy heifers under 20 months of 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