[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Rules and Regulations]
[Page 55824-55825]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-15]
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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 two strengths of pyrantel pamoate suspension in dogs
for the management of various internal parasites.
DATES: This rule is effective September 29, 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 200-352 for PRIMEX CANINE (pyrantel
pamoate) and PRIMEX CANINE-2X (pyrantel pamoate). PRIMEX CANINE
contains 2.27 milligrams (mg) pyrantel base per milliliter (/mL);
PRIMEX CANINE-2X contains 4.54 mg pyrantel base/mL. Both products are
for oral use in dogs and puppies for the removal of large roundworms
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum and Uncinaria stenocephala); and in dogs, puppies, and
lactating bitches to prevent reinfections of T. canis. First Priority's
PRIMEX CANINE and PRIMEX CANINE-2X are approved as generic copies of
Pfizer, Inc.'s RFD Suspension and NEMEX-2 Suspension, respectively,
approved under NADA 100-237. ANADA 200-352 is approved as of August 20,
2003, and the regulations are amended in Sec. 520.2043 (21 CFR
520.2043) to reflect the approval. The basis of approval is discussed
in the freedom of information summary. In addition, Sec. 520.2043 is
being amended to correct the spelling of one of the subject parasites.
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:
[[Page 55825]]
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)(2) by numerically adding ``058829,''; and in paragraph (d)(2)(i)(B)
by removing ``Toxascarias'' and by adding in its place ``Toxascaris''.
Dated: September 15, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-24493 Filed 9-26-03; 8:45 am]
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