Oral Dosage Form New Animal Drugs; Fenbendazole Suspension; Technical Amendment

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulation concerning veterinary prescription use of Hoechst Roussel Vet's fenbendazole suspension for cattle. The amendment clarifies the oral dose of fenbendazole suspension used as a dewormer in cattle.

Full text

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulation concerning veterinary prescription use of Hoechst 
Roussel Vet's fenbendazole suspension for cattle. The amendment 
clarifies the oral dose of fenbendazole suspension used as a dewormer 
in cattle.

EFFECTIVE DATE: November 18, 1998.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd., 
P.O. Box 4915, Warren, NJ 07059, is sponsor of new animal drug 
application (NADA) 128-620 that provides for oral, veterinary 
prescription use of Panacur (fenbendazole) 10 percent 
suspension. The drug is used as a dewormer in cattle, including dairy 
cattle of breeding age at 5 milligrams per kilogram (mg/kg) of body 
weight, and only in beef cattle at 10 mg/kg of body weight. The 
regulations are amended in 21 CFR 520.905a to clarify the approval.
    The amendments clarify the drug dose used to treat various classes 
of animals and insert certain technical revisions. No additional safety 
or effectiveness data were required. A revised freedom of information summary is provided to reflect the clarification.

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

    The authority citation for 21 CFR part 520 continues to read as 
follows:
    Authority: 21 U.S.C. 360b.
    2. Section 520.905a is amended by removing paragraph (a); by 
redesignating paragraphs (b) and (c) as paragraphs (a) and (b); by 
adding paragraph (c); by revising the heading of paragraph (d)(2); by 
redesignating paragraph (d)(3) as paragraph (d)(4); by redesignating 
paragraphs (d)(2)(ii), (d)(2)(ii)(A), and (d)(2)(ii)(B) as paragraphs 
(d)(3)(i), (d)(3)(ii), and (d)(3)(iii); by adding a heading for newly 
redesignated paragraph (d)(3); by redesignating paragraphs (d)(2)(i)(A) 
and (d)(2)(i)(B) as paragraphs (d)(2)(ii) and (d)(2)(iii) to read as 
follows:


Sec. 520.905a   Fenbendazole suspension.

* * * * *
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) * * *
    (2) Cattle including dairy cows of breeding age--* * *
* * * * *
    (3) Beef cattle--* * *
* * * * *

    Dated: November 9, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-30750 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F  

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