Document ID: FDA-2010-N-0002-0064
Agency: fda
Document Type: Rule
Title: Implantation and Injectable Dosage Form New Animal Drugs: Firocoxib
Posted Date: 2010-09-28T04:00Z

[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Rules and Regulations]               
[Page 59610-59611]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se10-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

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

 
Implantation and Injectable Dosage Form New Animal Drugs; 
Firocoxib

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 Merial Ltd. The NADA provides for the 
veterinary prescription use of firocoxib injectable solution in horses 
for the control of pain and inflammation associated with 
osteoarthritis.

DATES:  This rule is effective September 28, 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: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640 filed NADA 141-313 that provides for 
veterinary prescription use of EQUIOXX (firocoxib) Injection in horses 
for the control of pain and inflammation associated with 
osteoarthritis. The NADA is approved as of August 20, 2010, and the 
regulations are amended in 21 CFR part 522 by

[[Page 59611]]

adding new Sec.  522.930 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.
    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.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Add Sec.  522.930 to read as follows:

Sec.  522.930   Firocoxib.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) firocoxib.
    (b) Sponsors. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.04 mg/
pound (lb) (0.09 mg/kilogram (kg)) of body weight (BW) intravenously, 
once daily, for up to 5 days. If further treatment is needed, firocoxib 
oral paste can be administered at a dosage of 0.045 mg/lb (0.1 mg/kg) 
of BW for up to an additional 9 days of treatment.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: September 21, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-24254 Filed 9-27-10; 8:45 am]
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