Justia Regulation Tracker

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[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Rules and Regulations]               
[Page 51364-51365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se07-11]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; Etodolac

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 Fort Dodge Animal Health, Division of Wyeth. The NADA 
provides for veterinary prescription use of etodolac injectable 
solution in dogs for the control of pain and inflammation associated 
with osteoarthritis.

DATES: This rule is effective September 7, 2007.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501 filed NADA 141-274 that 
provides for veterinary prescription use of ETOGESIC (etodolac) 
Injectable in dogs for the control of pain and inflammation associated 
with osteoarthritis. The application is approved as of August 16, 2007, 
and part 522 (21 CFR part 522) is amended by adding Sec.  522.870 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.
    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.
    FDA has determined under 21 CFR 25.33(d)(1) 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 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:

[[Page 51365]]

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.  522.870 to read as follows:

Sec.  522.870  Etodolac.

    (a) Specifications. Each milliliter contains 100 milligrams (mg) 
etodolac.
    (b) Sponsor. See No. 000856 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 4.5 to 6.8 
mg/pound (10 to 15 mg/kilogram) body weight as a single, dorsoscapular 
subcutaneous injection. If needed, the daily dose of etodolac tablets 
as in Sec.  520.870 of this chapter may be given 24 hours after the 
injection.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: August 28, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-17645 Filed 9-6-07; 8:45 am]

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