FDA Approves New Antimicrobial Drug for Swine

Today, the U.S. Food and Drug Administration sanctioned Pradalex (pradofloxacin injection) solution for specific respiratory ailments in swine. Pradofloxacin belongs to the fluoroquinolone class of medically important antimicrobials and is authorized for use solely as a single injection under the prescription of a licensed veterinarian.

Over recent decades, the FDA has enacted policies to ensure that medically important antimicrobials, approved for animal use, are employed in a manner aligning with principles of antimicrobial stewardship. Notably, all medically important antimicrobials for animals necessitate the approval of a licensed veterinarian. The FDA holds that veterinarians, with their specialized training and expertise, play a pivotal role in antimicrobial stewardship, thereby mitigating the risks of antimicrobial resistance.

Pradalex, a 3rd generation fluoroquinolone categorized as critically important antimicrobial, carries labeling emphasizing its use only after considering alternative non-fluoroquinolone therapeutic options. Additionally, since 1997, the FDA has prohibited the extralabel use of fluoroquinolones, including Pradalex, in food-producing animals, except for indications approved by the agency.

The approval for Pradalex today pertains to its utilization in swine for treating swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae. The drug is sanctioned solely for weaned swine intended for slaughter, with no authorization for use in swine intended for breeding or nursing piglets.

The sponsor conducted multi-site field studies to establish the safety and efficacy of Pradalex in treating SRD in swine. Furthermore, the FDA evaluated the safety of edible products derived from swine treated with Pradalex.

Each mL of Pradalex comprises 200 mg of pradofloxacin and is available in 100 mL and 250 mL bottles. Administration involves subcutaneous injection in cattle at 10 mg/kg body weight and intramuscular injection in swine at 7.5 mg/kg body weight.

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