Animal drugs, feeds, and related products: New drug applications— Pyrantel pamoate suspension,

[Federal Register: August 28, 1998 (Volume 63, Number 167)]

[Rules and Regulations]

[Page 45944-45945]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28au98-14]

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) filedby 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 filedANADA 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 Nemex‹SUP›TM‹/SUP› and Nemex-2‹SUP›TM‹/SUP› (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. 98-23107Filed8-27-98; 8:45 am]

   BILLING CODE 4160-01-F