[Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
[Rules and Regulations]
[Pages 45944-45945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23107]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 use of pyrantel pamoate suspension for removal of large
roundworms and hookworms and to prevent reinfections of Toxocara canis
in puppies and adult dogs and in lactating bitches after whelping.
EFFECTIVE DATE: August 28, 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 has filed ANADA
200-248 that provides for oral use of pyrantel pamoate suspension for
removal of large roundworms (T. canis and Toxascaris leonina) and
hookworms (Ancylostoma caninum and Uncinaria stenocephala) and to
prevent reinfections of T. canis in puppies and adult dogs and in
lactating bitches after whelping.
The ANADA is approved as a generic copy of Pfizer, Inc.'s NADA 100-
237 NemexTM and Nemex-2TM (pyrantel pamoate)
suspension. ANADA 200-248 is approved as of July 16, 1998, and the
regulations are amended in 21 CFR 520.2043(b)(2) to reflect the
approval. The basis for 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
[[Page 45945]]
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)(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.
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 to read 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.
Sec. 520.2043 [Amended]
2. Section 520.2043 Pyrantel pamoate suspension is amended in
paragraph (b)(2) by removing ``Nos. 000069 and 011615'' and adding in
its place ``Nos. 000069, 011615, and 059130''.
Dated: August 20, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-23107 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F
