[Federal Register Volume 66, Number 3 (Thursday, January 4, 2001)]
[Rules and Regulations]
[Pages 712-713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-140]


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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; Gentamicin 
Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension

AGENCY: Food and Drug Administration

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 Schering-Plough Animal Health Corp. The NADA provides 
for veterinary prescription use of gentamicin/mometasone/clotrimazole 
otic suspension to treat otitis externa in dogs.

DATES: This rule is effective January 4, 2001.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed NADA 141-177 that provides for 
veterinary prescription use of Mometamax<SUP>TM</SUP> gentamicin 
sulfate/mometasone furoate/clotrimazole) Otic Suspension for the 
treatment of otitis externa associated with yeast (Malassezia 
pachydermatis) and/or bacteria susceptible to gentamicin in dogs. The 
NADA is approved as of December 5, 2000, and the regulations are 
amended in 21 CFR 524 by adding Sec. 524.1044h 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 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval 
qualifies for 3 years of marketing exclusivity beginning December 5, 
2000, because the application contains substantial evidence of 
effectiveness of the drug involved, or any studies of animal safety, 
required for approval of the application and conducted or sponsored by 
the applicant.
    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--OPTHALMIC 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 524.1044h is added to read as follows:


Sec. 524.1044h  Gentamicin sulfate, mometasone furoate, clotrimazole 
otic suspension.

    (a) Specifications. Each gram contains gentamicin sulfate, United 
States Pharmacopeia (USP) equivalent to 3-milligram (mg) gentamicin 
base, mometasone furoate monohydrate

[[Page 713]]

equivalent to 1-mg mometasone, and 10 mg clotrimazole, USP.
    (b) Sponsor. See No. 000061 in Sec. 510.6(c) of this chapter.
    (c) Conditions of use-- Dogs--(1) Amount. For dogs weighing less 
than 30 pounds (lb), instill 4 drops from the 5- and 30-gram (g) bottle 
into the ear canal (2 drops from the 215-g bottle) or, for dogs 
weighing 30 lb or more, instill 8 drops from the 5- and 30-g bottle 
into the ear canal (4 drops from the 215-g bottle), twice daily for 7 
days.
    (2) Indications for use. For the treatment of otitis externa 
associated with yeast (Malassezia pachydermatis) and/or bacteria 
susceptible to gentamicin in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-140 Filed 1-3-01; 8:45 am]
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