[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
[Pages 26646-26647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11245]
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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:
[email protected].
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.
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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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1616 [Amended]
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2. Revise the section heading of Sec. 520.1616 to read ``Orbifloxacin
tablets.''.
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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]
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