[Federal Register Volume 75, Number 19 (Friday, January 29, 2010)]
[Rules and Regulations]
[Pages 4692-4693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1794]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2010-N-0002]


Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, 
Polymixin B, and Prednisolone Suspension

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

-----------------------------------------------------------------------

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 Janssen Pharmaceutica NV. The NADA provides for use of 
miconazole nitrate, polymixin B sulfate, and prednisolone acetate for 
the treatment of otitis externa in dogs.

DATES: This rule is effective January 29, 2010.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Janssen Pharmaceutica NV, Turnhoutseweg 30, 
B-2340 Beerse, Belgium, filed NADA 141-298 that provides for veterinary 
prescription use of SUROLAN (miconazole nitrate, polymixin B sulfate, 
and prednisolone acetate) Otic Suspension in dogs for the treatment of 
otitis externa associated with

[[Page 4693]]

susceptible strains of yeast (Malassezia pachydermatis) and bacteria 
(Staphylococcus pseudintermedius). The NADA is approved as of November 
23, 2009, and the regulations are amended in 21 CFR part 524 by adding 
new 21 CFR 524.1445 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.
    FDA 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.
    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.
    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.

0
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.  524.1445 to read as follows:


Sec.  524.1445   Miconazole, polymixin B, and prednisolone suspension.

    (a) Specifications. Each milliliter of suspension contains 23 
milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 
5 mg prednisolone acetate.
    (b) Sponsor. See No. 012578 in 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill five drops in 
the ear canal twice daily for 7 consecutive days.
    (2) Indications for use. For the treatment of canine otitis externa 
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: January 22, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-1794 Filed 1-28-10; 8:45 am]
BILLING CODE 4160-01-S