Document ID: FDA-2011-N-0003-0050
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension
Posted Date: 2011-12-16T05:00Z

[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Rules and Regulations]
[Page 78150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32226]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2011-N-0003]

Ophthalmic and Topical Dosage Form New Animal Drugs; 
Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate 
Otic Suspension

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 original new animal drug 
application (NADA) filed by Virbac AH, Inc. The NADA provides for the 
veterinary prescription use of a hydrocortisone aceponate, miconazole 
nitrate, and gentamicin sulfate suspension for the treatment of otitis 
externa in dogs.

DATES: This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for 
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8322, email: 
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Fort 
Worth, TX 76137, filed NADA 141-330 for the veterinary prescription use 
of EASOTIC (hydrocortisone aceponate, miconazole nitrate, gentamicin 
sulfate) Suspension for the treatment of otitis externa in dogs 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (Staphylococcus pseudintermedius). The NADA is approved as 
of October 31, 2011, and 21 CFR part 524 is amended 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    The Agency has determined under 21 CFR 25.33 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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
2. Add Sec.  524.1132 to read as follows:

Sec.  524.1132  Hydrocortisone aceponate, miconazole nitrate, 
gentamicin sulfate otic suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 
1.11 milligrams (mg) of hydrocortisone aceponate, 15.1 mg of miconazole 
nitrate, and 1,505 micrograms of gentamicin sulfate.
    (b) Sponsor. See No.051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 1.0 mL in the 
affected ear once daily for 5 days.
    (2) Indications for use. For the treatment of otitis externa in 
dogs associated with susceptible strains of yeast (Malassezia 
pachydermatis) and bacteria (Staphylococcus pseudintermedius).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-32226 Filed 12-15-11; 8:45 am]
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