[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]
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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.
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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 and Safe-
Guard (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
