Document ID: FDA-2008-N-0039-0091
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream
Posted Date: 2008-12-29T05:00Z

[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Rules and Regulations]               
[Page 79318]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de08-9]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0039]

21 CFR Part 524

 
Ophthalmic and Topical Dosage Form New Animal Drugs; 
Triamcinolone Cream

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 an abbreviated new animal drug 
application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The 
ANADA provides for veterinary prescription use of triamcinolone cream 
on dogs for topical treatment of allergic dermatitis and summer eczema.

DATES: This rule is effective December 29, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 1550 
Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200-459 
that provides for veterinary prescription use of VETAZINE 
(triamcinolone acetonide) Cream on dogs for topical treatment of 
allergic dermatitis and summer eczema. Modern Veterinary Therapeutics, 
LLC's VETAZINE Cream is approved as a generic copy of VETALOG Cream, 
sponsored by Fort Dodge Animal Health, A Division of Wyeth Holdings 
Corp., under NADA 46-146. The ANADA is approved as of November 13, 
2008, and the regulations are amended in Sec.  524.2481 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.
    The agency has determined under 21 CFR 25.33(a)(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 522

    Animal drugs.

0
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 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.

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2. In Sec.  524.2481, revise paragraphs (b), (c)(2), and (c)(3) to read 
as follows:

Sec.  524.2481  Triamcinolone cream.

* * * * *
    (b) Sponsor. See Nos. 015914, 053501, and 054925 in Sec.  
510.600(c) of this chapter.
    (c) * * *
    (2) Indications for use. For topical treatment of allergic 
dermatitis and summer eczema.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 18, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-30694 Filed 12-24-08; 8:45 am]

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