[Federal Register Volume 69, Number 3 (Tuesday, January 6, 2004)]
[Rules and Regulations]
[Pages 499-500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Nitazoxanide Paste

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 IDEXX Pharmaceuticals, Inc. The NADA provides for 
veterinary prescription use of an nitazoxanide oral paste for the 
treatment of equine protozoal myeloencephalitis (EPM).

DATES: This rule is effective January 6, 2004.

[[Page 500]]


FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: IDEXX Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, filed NADA 141-178 for veterinary 
prescription use of NAVIGATOR (32 percent nitazoxanide) Antiprotozoal 
Oral Paste for the treatment of EPM caused by Sarcocystis neurona. The 
NADA is approved as of November 18, 2003, and 21 CFR part 520 is 
amended by adding new Sec.  520.1498 to reflect the approval. The basis 
of approval is discussed in the freedom of information summary.
    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 (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning November 18, 
2003.
    The agency 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 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. Section 520.1498 is added to read as follows:


Sec.  520.1498  Nitazoxanide paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.32 mg 
nitazoxanide.
    (b) Sponsor. See No. 065274 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. On days 1 through 5, 
administer 11.36 mg per pound (/lb) body weight; on days 6 through 28, 
administer 22.72 mg/lb body weight.
    (2) Indications for use--For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 23, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-129 Filed 1-5-04; 8:45 am]
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