[Federal Register: September 23, 2003 (Volume 68, Number 184)]
[Rules and Regulations]
[Page 55199]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se03-4]
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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:
lluther@cvm.fda.gov.
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.
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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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