Document ID: FDA-2011-N-0003-0058
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Gentamicin and Betamethasone Spray
Posted Date: 2012-01-25T05:00Z

[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Rules and Regulations]
[Page 3598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1501]

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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; Gentamicin 
and Betamethasone Spray

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 the original approval of an abbreviated new 
animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. 
The ANADA provides for the veterinary prescription use of gentamicin 
sulfate and betamethasone valerate topical spray in dogs.

DATES: This rule is effective January 25, 2012.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8197, email: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa, KS 66215, filed ANADA 200-416 that provides for 
veterinary prescription use of Gentamicin Topical Spray (gentamicin 
sulfate and betamethasone valerate) in dogs. Sparhawk Laboratories, 
Inc.'s Gentamicin Topical Spray is approved as a generic copy of 
Intervet, Inc.'s GENTOCIN Topical Spray, approved under NADA 132-338. 
The ANADA is approved as of November 10, 2011, and the regulations are 
amended in 21 CFR 524.1044f to reflect the approval and revised 
terminology in the indication.
    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 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.

Sec.  524.1044f  [Amended]

0
2. In Sec.  524.1044f, revise paragraphs (b) and (c)(2) to read as 
follows:

Sec.  524.1044f  Gentamicin and betamethasone spray.

* * * * *
    (b) Sponsors. See Nos. 000061, 054925, 058005, 058829, and 065531 
in Sec.  510.600(c) of this chapter.
    (c) * * *
    (2) Indications for use. For the treatment of infected superficial 
lesions caused by bacteria susceptible to gentamicin.
* * * * *

    Dated: January 19, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1501 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P