[Federal Register Volume 64, Number 141 (Friday, July 23, 1999)]
[Rules and Regulations]
[Pages 39918-39919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18769]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 Pfizer, Inc. The NADA provides for use of marbofloxacin 
tablets in dogs for the treatment of infections associated with 
bacteria susceptible to marbofloxacin.

EFFECTIVE DATE: July 23, 1999.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-151 ZeniquinTM (marbofloxacin) tablets 
for the treatment of infections in dogs associated with bacteria 
susceptible to marbofloxacin. The drug is limited to use by or on the 
order of a licensed veterinarian, and prohibited from extralabel use in 
food-producing animals. The NADA is approved as of June 26, 1999, and 
the regulations are amended by adding Sec. 520.1310 to reflect the 
approval. The

[[Page 39919]]

basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning June 26, 1999, 
because no active ingredient (including any ester or salt of the active 
ingredient) has been approved in any other application filed under 
section 512(b)(1) of the act.
    The agency has determined under 21 CFR 25.33(d)(1) 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.
    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.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
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

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

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

    2. Section 520.1310 is added to read as follows:


Sec. 520.1310   Marbofloxacin tablets.

    (a) Specifications. Each tablet contains either 25, 50, 100, or 200 
milligrams of marbofloxacin.
    (b)  Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 1.25 milligrams per 
pound of body weight once daily, but may be increased to 2.5 milligrams 
per pound of body weight once daily.
    (ii) Indications for use. For the treatment of infections in dogs 
associated with bacteria susceptible to marbofloxacin.
    (iii) Limitations. 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.

    Dated: July 15, 1999.
George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-18769 Filed 7-22-99; 8:45 am]
BILLING CODE 4160-01-F