[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Rules and Regulations]
[Page 39727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19713]
[[Page 39727]]
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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 Phoenix Scientific, Inc. The ANADA
provides for oral use pyrantel pamoate suspension as an anthelmintic to
treat horses and ponies.
EFFECTIVE DATE: July 24, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
246 that provides for oral use of 50 milligrams per milliliter (mg/mL)
pyrantel pamoate suspension in horses and ponies for 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.
Approval of ANADA 200-246 for Phoenix Scientific, Inc.'s pyrantel
pamoate suspension is as a generic copy of NADA 91-739 for Pfizer,
Inc.'s Strongid T (pyrantel pamoate) suspension. The ANADA is
approved as of June 18, 1998, and the regulations are amended in 21 CFR
520.2043(a)(2) 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 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 Dockets Management Branch (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.
The agency has determined under 21 CFR 25.33(a) 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.
List of Subjects in 21 CFR Part 520
Animal drugs.
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
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.2043 is amended by revising paragraph (a)(2) to read
as follows:
Sec. 520.2043 Pyrantel pamoate suspension.
(a) * * *
(2) Sponsors. See Nos. 000069 and 059130 in Sec. 510.600(c) of this
chapter.
* * * * *
Dated: July 15, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19713 Filed 7-23-98; 8:45 am]
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