[Federal Register Volume 60, Number 80 (Wednesday, April 26, 1995)]
[Rules and Regulations]
[Pages 20401-20402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10273]
=======================================================================
-----------------------------------------------------------------------
[[Page 20402]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Lufenuron 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 a new animal drug application
(NADA) filed by Ciba Animal Health, Ciba-Geigy Corp. The NADA provides
for oral administration of lufenuron suspension to cats for the control
of flea populations.
EFFECTIVE DATE: April 26, 1995.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Ciba Animal Health, Ciba-Geigy Corp., P.O.
Box 18300, Greensboro, NC 27419-8300, filed NADA 141-026, which
provides for oral administration of Program (Lufenuron)
Suspension to cats 6 weeks of age or older. The drug is provided once a
month, mixed in food, for the control of flea populations. The product
contains six individual dose packs of 135 or 270 milligrams lufenuron.
Lufenuron has no deleterious effect on adult fleas, but it prevents
most flea eggs from hatching or maturing into adults. The NADA is
approved as of March 28, 1995, and the regulations are amended in part
520 (21 CFR 520) by adding new Sec. 520.1289 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning March 28, 1995, because it
contains reports of new clinical or field investigations, other than
bioequivalence or residue studies, essential to the approval and
conducted or sponsored by the applicant.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. New Sec. 520.1289 is added to read as follows:
Sec. 520.1289 Lufenuron suspension.
(a) Specifications. Each individual dose pack contains either 135
or 270 milligrams of lufenuron.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Minimum of 13.6
milligrams per pound of body weight (30 milligrams per kilogram).
Recommended dose of 135 milligrams for up to 10 pounds of body weight
or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided
the appropriate combination of packs.
(2) Indications for use. For control of flea populations.
(3) Limitations. For oral use in cats 6 weeks of age or older,
once a month, mixed with food. Administer in conjunction with a full
meal to ensure adequate absorption. Treat all cats in the household to
ensure maximum benefits. Because the drug has no affect on adult fleas,
the concurrent use of insecticides that kill adults may be necessary
depending on the severity of the infestation. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Dated: April 19, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-10273 Filed 4-25-95; 8:45 am]
BILLING CODE 4160-01-F
