[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Rules and Regulations]
[Pages 70053-70054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine 
Suspension

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 Animal Health Pharmaceuticals, LLC. The NADA provides 
for veterinary prescription use of an oral suspension of sulfadiazine 
and pyrimethamine for the treatment of equine protozoal 
myeloencephalitis (EPM).

DATES: This rule is effective December 2, 2004.

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: Animal Health Pharmaceuticals, LLC, 1805 Oak 
Ridge Circle, suite 101, St. Joseph, MO 64506, filed NADA 141-240 for 
veterinary prescription use of REBALANCE (sulfadiazine/pyrimethamine) 
Antiprotozoal Oral Suspension for the treatment of EPM caused by 
Sarcocystis neurona. The NADA is approved as of November 5, 2004, and 
21 CFR part 520 is amended by adding new Sec.  520.2215 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, Animal Health Pharmaceuticals, LLC, is not currently 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    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

[[Page 70054]]

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 November 5, 2004.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Animal Health Pharmaceuticals, 
LLC''; and in the table in paragraph (c)(2) by numerically adding an 
entry for ``068718'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
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                                * * * * *
Animal Health Pharmaceuticals, LLC, 1805 Oak   068718
 Ridge Circle, suite 101, St. Joseph, MO
 64506
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
068718....................  Animal Health Pharmaceuticals, LLC, 1805 Oak
                             Ridge Circle, suite 101, St. Joseph, MO
                             64506
                                * * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
0
4. Section 520.2215 is added to read as follows:


Sec.  520.2215  Sulfadiazine/pyrimethamine suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 250 
milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg 
pyrimethamine.
    (b) Sponsor. See No. 068718 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 20 
mg sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine 
daily.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: November 23, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-26528 Filed 12-1-04; 8:45 am]
BILLING CODE 4160-01-S