FDA Grants Conditional Approval for New Baytril 100-CA1 Injection

Bayer Animal Health has received conditional approval from the FDA for its new injectable anaplasmosis treatment. ( Bayer Animal Health )

It is estimated U.S. cattle producers lose up to $300 million each year because of bovine anaplasmosis1, and cases of the disease have been diagnosed in 48 states.2 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.

“Options to address clinical anaplasmosis in cattle have been limited,” said Sebastian Kuszmierczyk, Head of Farm Animal Products in the U.S. for Bayer Animal Health. “This conditional approval allows us to offer the proven efficacy of enrofloxacin as a new treatment for this potentially deadly disease.”

About Bovine Anaplasmosis

Anaplasmosis is a vector-borne, infectious blood disease usually spread by ticks. The feeding tick transmits the bacteria that infects red blood cells and cause severe anemia. The disease is most devastating to cows ages 3 and older. While younger animals can become infected, calves less than a year old that are infected usually do not show clinical signs of the disease but will become carriers. Cows infected with the disease that recover will continue to be carriers their entire lives.

Much like bovine respiratory disease (BRD), anaplasmosis can be hard to detect. Anemia and weakness are frequently the first clinical signs. Infected cattle will fall behind the rest of the herd and will not eat or drink. Weight loss is rapid. Cattle can become extremely aggressive if they are oxygen deprived due to the severe anemia. Oxygen deprivation can also result in abortions in pregnant cows. Constipation, high fever and labored breathing can also be seen. The most critical period is the first four to nine days after clinical signs appear.

Limited Treatment Options

Until now, tetracycline antimicrobials, oxytetracycline injectables or chlortetracycline medicated feed, were the only drugs used in the U.S. for treatment of acute anaplasmosis. In some places, vaccines are also available to increase resistance to anaplasmosis.

“Our recent research has shown that some of the currently available anaplasmosis treatment options may not be as effective as in the past,” according to Kathryn Reif, MSPH, Ph.D., Department of Diagnostic Medicine/Pathobiology in the College of Veterinary Medicine at Kansas State University. “A new treatment option to manage clinical anaplasmosis is a welcome option for veterinarians and producers.”

About Baytril® 100-CA1

Baytril® 100-CA1 contains the proven molecule, enrofloxacin, and is indicated for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age, all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding of any age. Not for use in any other class of dairy cattle or in veal calves.

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 administered for the conditionally approved dosage regimen based on published scientific literature and reports from studies conducted by the sponsor. Enrofloxacin treatment in A. marginale-infected cattle resulted in a decrease in parasitemia and, when evaluated, improvement in clinical variables (hematocrit and rectal temperatures).

Enrofloxacin has been shown to have no adverse effects on cow reproductive performance, pregnancy and lactation, and no effect on calf viability and health.

Federal (U.S.A.) law restricts Baytril 100-CA1 to use by or on the order of a licensed veterinarian. Federal (U.S.A.) 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 use in 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 in calves born to these cows. 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.

For more 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.

1Kocan KM, Fuente J, Guglielmone AA, et al. (2003). Antigens and alternatives for control of anaplasma marginale infection in cattle. Clin Microbiol Rev. 16(4):698–712.
2Coetzee JF, Schmidt PL, O'Connor AM, Apley MD. Seroprevalence of Anaplasma marginale in 2 Iowa feedlots and its association with morbidity, mortality, production parameters, and carcass traits. Can Vet J. 2010;51(8):862–868.