21 CFR § 520.1618 - Orbifloxacin suspension.

---
identifier: "/us/cfr/t21/s520.1618"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1618 - Orbifloxacin suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1618"
section_name: "Orbifloxacin suspension."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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.*

[75 FR 26646, May 12, 2010]