98-19713. Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension  

  • [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]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
7/24/1998
Published:
07/24/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-19713
Dates:
July 24, 1998.
Pages:
39727-39727 (1 pages)
PDF File:
98-19713.pdf
CFR: (1)
21 CFR 520.2043