[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Rules and Regulations]
[Pages 34795-34796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Tepoxalin

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 Schering-Plough Animal Health Corp. The NADA provides 
for the veterinary prescription use of tepoxalin tablets for the 
control of pain and inflammation associated with osteoarthritis in 
dogs.

DATES: This rule is effective June 11, 2003.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 
07083, filed NADA 141-193 that provides for veterinary prescription use 
of ZUBRIN (tepoxalin) Tablets for the control of pain and inflammation 
associated with osteoarthritis in dogs. The NADA is approved as of 
March 31, 2003, and the regulations in part 520 (21 CFR part 520) are 
amended by adding new Sec.  520.2340 to reflect the approval. The 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 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 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 March 31, 
2003.
    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.

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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

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

     Authority: 21 U.S.C. 360b.
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2. Section 520.2340 is added to read as follows:


Sec.  520.2340  Tepoxalin.

    (a) Specifications. Each tablet contains 30, 50, 100, or 200 
milligrams (mg) tepoxalin.

[[Page 34796]]

    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 mg per kilogram (/kg) 
daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/
kg daily.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: May 27, 2003.
Steven F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-14678 Filed 6-10-03; 8:45 am]
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