Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 520.1618: Orbifloxacin suspension.

(a) Specifications. Each milliliter of suspension contains 30 milligrams (mg) orbifloxacin.
(b) Sponsor. See No. 000061 in 510.600(c) of this chapter.
(c) Special considerations. 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.
(d) Conditions of use—(1) Dogs—(i) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight once daily.
(ii) Indications for use. For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli, and Enterococcus faecalis and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase-positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter spp., E. faecalis, β-hemolytic streptococci (Group G), and Streptococcus equisimilis.
(2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/kg) of body weight once daily.
(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of S. aureus, E. coli, and P. multocida.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

(c) Special considerations. 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.

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

(ii) Indications for use. For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli, and Enterococcus faecalis and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase-positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter spp., E. faecalis, β-hemolytic streptococci (Group G), and Streptococcus equisimilis.

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

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

Collected 2026-08-27T02:24:47Z. Source file · JSON

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