Document ID: FDA-2010-N-0002-0075
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Domperidone
Posted Date: 2010-11-01T04:00Z

[Federal Register: November 1, 2010 (Volume 75, Number 210)]
[Rules and Regulations]               
[Page 67031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no10-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

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

 
Oral Dosage Form New Animal Drugs; Domperidone

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 the original approval of a new animal drug 
application (NADA) filed by Dechra, Ltd. The NADA provides for the 
veterinary prescription use of domperidone oral gel for prevention of 
fescue toxicosis in periparturient mares.

DATES: This rule is effective November 1, 2010.

FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8336, e-mail: amy.omer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage 
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, 
United Kingdom, filed NADA 141-314 that provides for veterinary 
prescription use of EQUIDONE (domperidone) Gel for prevention of fescue 
toxicosis in periparturient mares. The NADA is approved as of September 
9, 2010, and the regulations in 21 CFR part 520 are amended by adding 
Sec.  520.766 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)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning on the date of approval.
    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.
    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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

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2. Add Sec.  520.766 to read as follows:

Sec.  520.766  Domperidone.

    (a) Specifications. Each milliliter of gel contains 110 milligrams 
(mg) domperidone.
    (b) Sponsor. See No. 043264 in Sec.  510.600 of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.5 mg per 
pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 
15 days prior to the expected foaling date. Treatment may be continued 
for up to 5 days after foaling if mares are not producing adequate 
milk.
    (2) Indications for use. For prevention of fescue toxicosis in 
periparturient mares.
    (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: October 27, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27524 Filed 10-29-10; 8:45 am]
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