[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Page 42831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20254]
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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 Med-Pharmex, Inc. The ANADA provides for
use of nystatin, neomycin, thiostrepton, and triamcinolone acetonide
vanishing cream base ointment for topical management of dermatologic
disorders of dogs and cats.
EFFECTIVE DATE: August 6, 1999.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861, filed ANADA 200-245 that provides for veterinary
prescription use of Derma-Vet Cream (nystatin, neomycin, thiostrepton,
and triamcinolone acetonide) for topical management of dermatologic
disorders in dogs and cats characterized by inflammation and dry or
exudative dermatitis, particularly those caused, complicated, or
threatened by bacterial or candidal (Candida albicans) infections.
Med-Pharmex's ANADA 200-245 is approved as a generic copy of
Solvay's NADA 96-676 for Panalog Cream. The ANADA is approved
as of June 7, 1999. The basis for approval is discussed in the freedom
of information summary.
The regulation in Sec. 524.1600a (21 CFR 524.1600a) does not
designate which approvals are for petrolatum base products (ointments)
and which are for vanishing cream base products (creams). The
regulation in Sec. 524.1600a(b) is amended at this time to designate
the base of each sponsor's product and to reflect this approval.
In addition, due to enactment of the Generic Animal Drug and Patent
Term Restoration Act of 1988, the footnote concerning the National
Academy of Sciences/National Research Council review is outdated. At
this time, the footnote and the footnote references are removed.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 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.
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.
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
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 524.1600a is amended by revising paragraph (b) and by
removing the footnote of paragraphs (c)(1)(i), (c)(1)(ii), (c)(1)(iii),
(c)(2)(i), and (c)(2)(ii) to read as follows:
Sec. 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone
acetonide ointment.
* * * * *
(b) Sponsors. For petrolatum base ointments see 000031, 000069,
000332, 025463, 051259, and 053501 in Sec. 510.600(c) of this chapter.
For vanishing cream base ointments see 051259 and 053501.
* * * * *
Dated: June 29, 1999
George A. Mitchell,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-20254 Filed 8-5-99; 8:45 am]
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