Document ID: FDA-2010-N-0002-0025
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Orbifloxacin, Mometasone Furoate Monohydrate, and Posaconazole Suspension
Posted Date: 2010-04-01T04:00Z

[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]               
[Page 16346-16347]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap10-12]                         

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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; 
Orbifloxacin, Mometasone Furoate Monohydrate, and Posaconazole 
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 a new animal drug application 
(NADA) filed by Intervet, Inc. The NADA provides for the veterinary 
prescription use of a suspension containing orbifloxacin, mometasone 
furoate monohydrate, and posaconazole for the treatment of otitis 
externa in dogs.

DATES:  This rule is effective April 1, 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, email: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, filed NADA 141-266 that provides for veterinary 
prescription use of POSATEX (orbifloxacin, mometasone furoate 
monohydrate, and posaconazole) Otic Suspension for the treatment of 
otitis externa in dogs associated with susceptible strains of yeast 
(Malassezia pachydermatis) and bacteria (coagulase-positive 
staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis). The 
NADA is approved as of February 18, 2010, and the regulations are 
amended in 21 CFR part 524 by adding Sec.  524.1610 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.  524.1610 to read as follows:

Sec.  524.1610  Orbifloxacin, mometasone furoate monohydrate, and 
posaconazole suspension.

    (a) Specifications. Each gram of suspension contains 10 milligrams 
(mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg 
mometasone furoate, and 1 mg posaconazole.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. For dogs weighing less 
than 30 lbs. instill 4 drops once daily into the ear canal. For dogs 
weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy 
should continue for 7 consecutive days.

[[Page 16347]]

    (2) Indications for use. For the treatment of otitis externa 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, 
and Enterococcus faecalis).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 24, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-7163 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S