[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54803]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-4]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by First Priority, Inc. The ANADA provides
for oral use of pyrantel pamoate suspension in horses and ponies for
the removal and control of various internal parasites.
DATES: This rule is effective September 19, 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: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-353 for PRIMEX (pyrantel pamoate)
Equine Anthelmintic Suspension for oral use in horses and ponies for
the removal and control of various internal parasites. First Priority's
PRIMEX Equine Anthelmintic Suspension is approved as a generic copy of
Pfizer, Inc.'s STRONGID T, approved under NADA 91-739. ANADA 200-353 is
approved as of August 19, 2003, and the regulations are amended in 21
CFR 520.2043 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.
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 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.
Sec. 520.2043 [Amended]
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2. Section 520.2043 Pyrantel pamoate suspension is amended in paragraph
(b)(1) by removing ``000069'' and adding in its place ``000069,
058829,''.
Dated: September 11, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-23943 Filed 9-18-03; 8:45 am]
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