Document ID: FDA-2010-N-0002-0043
Agency: fda
Document Type: Rule
Title: Oral Dosages Form New Animal Drugs: Orbifloxacin Suspension
Posted Date: 2010-05-12T04:00Z

[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]               
[Page 26646-26647]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my10-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2010-N-0002]

 
Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Intervet, Inc. The NADA provides for the veterinary 
prescription use of an oral suspension containing orbifloxacin for the 
treatment of various bacterial infections in dogs and cats.

DATES:  This rule is effective May 12, 2010.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, filed NADA 141-305 that provides for veterinary 
prescription use of ORBAX (orbifloxacin) Oral Suspension for the 
treatment of various bacterial infections in dogs and cats. The NADA is 
approved as of March 25, 2010, and the regulations are amended in 21 
CFR part 520 by adding new Sec.  520.1618 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33 that this action is of a type 
that does not individually or cumulatively have a significant effect on 
the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.1616   [Amended]

0
2. Revise the section heading of Sec.  520.1616 to read ``Orbifloxacin 
tablets.''.

0
3. Add Sec.  520.1618 to read as follows:

Sec.  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, [beta]-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

[[Page 26647]]

susceptible strains of S. aureus, E. coli, and P. multocida.

    Dated: May 6, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-11245 Filed 5-11-10; 8:45 am]
BILLING CODE 4160-01-S