[Federal Register Volume 68, Number 139 (Monday, July 21, 2003)]
[Rules and Regulations]
[Pages 42967-42968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Meloxicam

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 Boehringer Ingelheim Vetmedica, Inc. The NADA provides 
for use of meloxicam oral suspension for the control of pain and 
inflammation associated with osteoarthritis in dogs.

DATES:  This rule is effective July 21, 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: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-213 that 
provides for use of METACAM (meloxicam) Oral Suspension for the control 
of pain and inflammation associated with osteoarthritis in dogs. The 
NADA is approved as of April 15, 2003, and the regulations are amended 
in 21 CFR part 520 by adding new Sec.  520.1350 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 part 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

[[Page 42968]]

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 April 15, 
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 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.

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2. Section 520.1350 is added to read as follows:


Sec.  520.1350   Meloxicam.

    (a) Specifications. Each milliliter of suspension contains 0.5 or 
1.5 milligrams (mg) meloxicam.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for 
uses as in paragraph (c) of this section.
    (c) Conditions of use in dogs--(1) Amount. Administer orally 0.2 
mg/kilogram (kg) body weight on the first day of treatment. For all 
treatment after day 1, administer 0.1 mg/kg body weight once 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: July 8, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-18354 Filed 7-18-03; 8:45 am]
BILLING CODE 4160-01-S