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Ophthalmic and Topical Dosage Form New Animal Drugs; Nystatin, Neomycin, Thiostrepton, and Triamcinolone Acetonide Ointment

 [Federal Register: September 23, 2003 (Volume 68, Number 184)]
[Rules and Regulations]
[Page 55201]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se03-7]

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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; Nystatin, 
Neomycin, Thiostrepton, and Triamcinolone Acetonide Ointment

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 Altana, Inc. The ANADA provides for 
topical dermatologic use in dogs and cats of a nystatin, neomycin, 
thiostrepton, and triamcinolone acetonide ointment in a vanishing cream 
base.

DATES: This rule is effective September 23, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
lluther@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Altana, Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-330 that provides for use of ANIMAX (nystatin, 
neomycin, thiostrepton, and triamcinolone acetonide) Cream Veterinary, 
a vanishing cream based ointment, for topical dermatologic use in dogs 
and cats. Altana, Inc.'s ANIMAX Cream Veterinary is approved as a 
generic copy of Fort Dodge Animal Health's PANOLOG Cream, approved 
under NADA 96-676. The ANADA is approved as of September 4, 2003, and 
the regulations in 21 CFR 524.1600a are amended 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.
    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 524

    Animal drugs.

? 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:

OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  524.1600a  [Amended]

? 2. Section 524.1600a Nystatin, neomycin, thiostrepton, and 
triamcinolone acetonide ointment is amended in paragraph (b) in the 
second sentence by removing ``051259 and 053501'' and by adding in its 
place ``Nos. 025463, 051259, and 053501''.

    Dated: September 15, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-24160 Filed 9-22-03; 8:45 am]
BILLING CODE 4160-01-S

 
 

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