April 9, 2024

Today, the U.S. Food and Drug Administration approved Pradalex (pradofloxacin injection) 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. 

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.

Pradalex 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, non-fluoroquinolone therapeutic options. Additionally, since 1997, the FDA has prohibited the extralabel use of fluoroquinolones, such as Pradalex, in food-producing animals for any indication other than those the agency has approved. 

Today’s approval for Pradalex is in certain ages and classes of cattle for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. The drug may only be prescribed for cattle intended for slaughter and cattle intended for breeding that are less than 1 year of age; it is not 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 agency also approved Pradalex for use in swine for the treatment of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae. The drug may only be prescribed for weaned swine intended for slaughter; it is not for use in swine intended for breeding or nursing piglets.

The sponsor conducted multi-site field studies to demonstrate that Pradalex 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 Pradalex. 

Each mL of Pradalex contains 200 mg of pradofloxacin. Pradalex 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.

Pradalex is sponsored by Elanco US Inc. based in Greenfield, Indiana.

Source from FDA:https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-new-antimicrobial-drug-cattle-and-swine

100ml PP vaccine vial

250ml PE plastic vaccine bottle