[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
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:
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.
Sec. 524.1600a [Amended]
0
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