Antimicrobial drug for cattle and swine receives FDA approval

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Officials with the FDA have approved pradofloxacin injection (Pradalex; Elanco) solution for certain respiratory diseases in cattle and swine. Pradofloxacin is a medically important antimicrobial in the fluoroquinolone class and may only be prescribed by a licensed veterinarian as a single injection, according to the FDA.

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The FDA’s approval for this pradofloxacin injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in cattle intended for slaughter and cattle intended for breeding that are less than 1 year of age. Notably, it is not approved for use in cattle intended for breeding 1 year of age and older, beef calves less than 2 months of age, dairy calves, and veal calves.

The FDA also approved pradofloxacin injection for the treatment of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in weaned swine intended for slaughter. This prescription drug is not indicated for use in swine intended for breeding or nursing piglets.Each mL of the approved product contains 200 mg of pradofloxacin, and it is supplied in 100 mL and 250 mL bottles. The drug is administered by subcutaneous injection in cattle at 10 mg/kg body weight and by intramuscular injection in swine at 7.5 mg/kg body weight.

Over the past several decades, the FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals are used in a manner that is consistent with principles of antimicrobial stewardship. For example, all medically important antimicrobials for animals require the authorization of a licensed veterinarian because the FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance.

Elanco’s pradofloxacin injection is a 3rd generation fluoroquinolone, which is ranked as a critically important antimicrobial, and the labeling of the drug includes a statement that it should be used only after considering other, nonfluoroquinolone therapeutic options. Additionally, since 1997, the FDA has prohibited the extra label use of fluoroquinolones, such as pradofloxacin injection, in food-producing animals for any indication other than those the agency has approved.

The sponsor conducted multi-site field studies to demonstrate that pradofloxacin injection is safe and effective for treating BRD in cattle and SRD in swine. The FDA also assessed the safety of edible products from cattle and swine treated with this drug.

Reference

FDA approves new antimicrobial drug for cattle and swine. News release. FDA. April 9, 2024. Accessed April 9, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-new-antimicrobial-drug-cattle-and-swine?utm_medium=email&utm_source=govdelivery