[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Rules and Regulations]
[Pages 29551-29552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14298]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Lufenuron Suspension
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 new animal drug application
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for
subcutaneous use of lufenuron suspension in cats for control of flea
populations.
EFFECTIVE DATE: June 1, 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: Novartis Animal Health US, Inc., P.O. Box
26402, Greensboro, NC 27404-6402, is the sponsor of NADA 141-105 that
provides for the subcutaneous use of ProgramTM (lufenuron)
10 percent sterile suspension for cats for the control of flea
populations. The drug is limited to use by or on the order of a
licensed veterinarian. The NADA is approved as of March 13, 1998, and
the regulations are amended by adding Sec. 522.1289 to reflect the
approval. The basis of
[[Page 29552]]
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.
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.
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 13, 1998, because the
application contains substantial evidence of the effectiveness of the
drug involved or studies of target animal safety required for approval
of the application and conducted or sponsored by the applicant.
List of Subjects in 21 CFR Part 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.1289 is added to read as follows:
Sec. 522.1289 Lufenuron suspension.
(a) Specifications. Each milliliter of sterile aqueous suspension
contains 10 milligrams of lufenuron.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Cats--(i) Amount. 10 milligrams per
kilogram (4.5 milligrams per pound) of body weight every 6 months,
subcutaneously.
(ii) Indications for use. For use in cats 6 weeks of age and older,
for control of flea populations. Lufenuron controls flea populations by
preventing the development of flea eggs and does not kill adult fleas.
Concurrent use of insecticides may be necessary for adequate control of
adult fleas.
(iii) Limitations. For subcutaneous use in cats only. The safety of
this product in reproducing animals has not been established. Do not
use in dogs. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(2) [Reserved]
Dated: May 12, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-14298 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F
