[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Rules and Regulations]
[Page 12085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Lufenuron Tablet
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 Ciba-Geigy Animal Health, Ciba-Geigy Corp.
The supplemental NADA provides for oral administration of lufenuron
tablets at a minimum dose of 30 milligrams per kilogram (mg/kg) for the
control of flea populations on cats.
EFFECTIVE DATE: March 14, 1997.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish P1., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Ciba-Geigy Animal Health, Ciba-Geigy Corp.,
P.O. Box 18300, Greensboro, NC 27419-8300, filed supplemental NADA 141-
035, which provides for oral administration of Program
(lufenuron) tablets to cats 6 weeks of age or older. The drug is
approved in 90- or 204.9-mg tablets, given once a month, directly or
broken and mixed into wet food, for the control of flea populations.
Lufenuron has no deleterious effect on adult fleas but it prevents most
flea eggs from hatching or maturing into adults. The supplemental NADA
is approved as of January 23, 1997, and the regulations are amended in
21 CFR 520.1288 by revising the heading for paragraph (c) and by adding
new paragraph (d) 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 (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning January 23, 1997,
because the application contains substantial evidence of effectiveness
of the drug involved, studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence
or residue studies) required for approval and conducted or sponsored by
the applicant.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.1288 is amended by revising the heading for
paragraph (c) and by adding new paragraph (d) to read as follows:
Sec. 520.1288 Lufenuron tablets.
* * * * *
(c) Conditions of use in dogs--
* * * * *
(d) Conditions of use in cats--(1) Amount. 90-milligram tablet for
cats up to 6 pounds of body weight, 204.9-milligram tablet for cats 7
to 15 pounds, a combination of tablets for cats over 15 pounds (a
minimum of 13.6 milligrams per pound (30 milligrams per kilogram)).
(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, directly or broken and mixed into wet 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.
Dated: February 11, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-6412 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F
