[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Rules and Regulations]
[Pages 40766-40767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac

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 IDEXX Pharmaceuticals, Inc. The NADA provides for 
topical use of diclofenac cream in horses for the control of pain and 
inflammation associated with osteoarthritis in tarsal, carpal, 
metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal 
(hock, knee, fetlock, and pastern) joints.

DATES:  This rule is effective July 7, 2004.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: IDEXX Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, filed NADA 141-186 that provides 
for use of SURPASS (1 % diclofenac sodium) Topical Cream in horses for 
the control of pain and inflammation associated with osteoarthritis in 
tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal 
interphalangeal (hock, knee, fetlock and pastern) joints. The NADA is 
approved

[[Page 40767]]

as of May 13, 2004, and the regulations are amended in 21 CFR part 524 
by adding Sec.  524.590 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 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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning May 13, 2004.
    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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.
0
2. Section 524.590 is added to read as follows:


Sec.  524.590   Diclofenac.

    (a) Specifications. Each gram of cream contains 10 milligrams 
diclofenac sodium.
    (b) Sponsor. See No. 065274 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Apply a 5-inch (5'') 
ribbon of cream twice daily over the affected joint for up to 10 days 
and rub thoroughly into the hair covering the joint until it 
disappears.
    (2) Indications for use in horses. For the control of pain and 
inflammation associated with osteoarthritis in tarsal, carpal, 
metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal 
(hock, knee, fetlock and pastern) joints.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: June 17, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-15426 Filed 7-6-04; 8:45 am]
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