§ 520.1618 Orbifloxacin suspension.

Specifications.(a) Each milliliter of suspension contains 30 milligrams (mg) orbifloxacin.

Sponsor.(b) See No. 000061 in 510.600(c) of this chapter.

Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

Conditions of useDogsAmount.(d) —(1) —(i) 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight once daily.

Indications for use.Staphylococcus pseudintermediusProteus mirabilisEscherichia coli,Enterococcus faecalisStaphylococcus pseudintermediusStaphylococcus aureusPasteurella multocidaProteus mirabilisPseudomonasKlebsiella pneumoniaeE. coliEnterobacterCitrobacterE. faecalisStreptococcus equisimilis.(ii) For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of , , and and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of , , coagulase-positive staphylococci, , , spp., , , spp., spp., , β-hemolytic streptococci (Group G), and

CatsAmount.(2) —(i) 3.4 mg/lb (7.5 mg/kg) of body weight once daily.

Indications for use.S. aureusE. coliP. multocida.(ii) For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of , , and

[75 FR 26646, May 12, 2010]