[Federal Register Volume 68, Number 184 (Tuesday, September 23, 2003)]
[Rules and Regulations]
[Page 55199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for over-the-counter marketing status for 
pyrantel pamoate suspension, when labeled for oral administration to 
horses and ponies for the removal and control of certain internal 
parasites.

DATES: This rule is effective September 23, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855; 301-827-8549; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed a supplement to ANADA 200-246 
that currently provides for the veterinary prescription use of 
ANTHELBAN V (pyrantel pamoate) Equine Anthelmintic Suspension, 
administered orally or by nasogastric tube (stomach tube) to horses and 
ponies for the removal and control of mature infections of large 
strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms 
(Oxyuris equi); large roundworms (Parascaris equorum); and small 
strongyles. The supplemental ANADA provides for the over-the-counter 
use of Pyrantel Pamoate Equine Anthelmintic Suspension, an identical 
formulation labeled for the same conditions of use, except 
administration by stomach tube, a veterinary procedure. Phoenix 
Scientific, Inc.'s Pyrantel Pamoate Equine Anthelmintic Suspension is 
approved as a generic copy of Pfizer, Inc.'s PAMOBAN Horse Wormer 
Suspension, approved with over-the-counter marketing status under NADA 
91-739. The supplemental ANADA is approved as of August 19, 2003, and 
the regulations are amended in 21 CFR 520.2043 to reflect the approval 
and the current indications for use. 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.
    FDA has determined under 21 CFR 25.33(a)(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.

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 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.
0
2. Section 520.2043 is amended by revising paragraph (d)(1)(ii) to read 
as follows:


Sec.  520.2043  Pyrantel pamoate suspension.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the removal and control of mature 
infections of large strongyles (Strongylus vulgaris, S. edentatus, S. 
equinus); pinworms (Oxyuris equi); large roundworms (Parascaris 
equorum); and small strongyles.
* * * * *

    Dated: September 15, 2003.
Steven D. Vaughn.
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-24162 Filed 9-22-03; 8:45 am]
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