[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Rules and Regulations]
[Page 31624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15480]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Fenbendazole Paste

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 a supplemental new animal drug 
application (NADA) filed by Hoechst Roussel Vet. The supplemental NADA 
provides for expanding the indications to include treatment of encysted 
mucosal cyathostome (small strongyle) larvae including early third 
stage (hypobiotic), late third stage, and fourth stage larvae.

EFFECTIVE DATE: June 10, 1998.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd., 
P.O. Box 4915, Warren, NJ 07059, filed supplemental NADA 120-648 that 
provides for oral administration of Panacur<Register> and Safe-
Guard<Register> (fenbendazole l0 percent) paste to horses. The product 
is currently approved for use concomitantly with an approved form of 
trichlorfon. Trichlorfon is approved for the treatment of stomach bots 
(Gasterophilus spp.) in horses. The supplemental NADA provides for 
expanding the indications to include treatment of encysted mucosal 
cyathostome (small strongyle) larvae including early third stage 
(hypobiotic), late third stage, and fourth stage larvae when 
administered at 10 milligrams per kilogram per day for 5 consecutive 
days. The supplemental NADA is approved as of April 20, 1998, and the 
regulations are amended in 21 CFR 520.905c(d)(1)(iii) 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 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act, this approval for nonfood-producing animals qualifies for 
3 years of marketing exclusivity beginning April 20, 1998, because the 
supplemental application contains substantial evidence of the 
effectiveness of the drug involved, or any studies of animal safety, 
required for approval of the application and conducted or sponsored by 
the applicant.
    The agency has determined under 21 CFR 25.33(d)(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 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 520.905c is amended by adding paragraph (d)(1)(iii) to 
read as follows:


Sec. 520.905c  Fenbendazole paste.

* * * * *
    (d) * * *
    (1) * * *
    (iii)(a) Amount. 4.6 milligrams per pound of body weight (10 
milligrams per kilogram) daily for 5 consecutive days.
    (b) Indications for use. For treatment of encysted mucosal 
cyathostome (small strongyle) larvae including early third stage 
(hypobiotic), late third stage, and fourth stage larvae in horses.
    (c) Limitations. (Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of encysted mucosal cyathostomes). Do 
not use in horses intended for food.
* * * * *

    Dated: May 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-15480 Filed 6-9-98; 8:45 am]
BILLING CODE 4160-01-F