[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Rules and Regulations]
[Pages 59610-59611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24254]
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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:
[email protected].
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.
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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
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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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