[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Rules and Regulations]
[Page 78150]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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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