[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Rules and Regulations]
[Pages 41189-41190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Milbemycin Oxime/Lufenuron
Tablets
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 Novartis Animal Health US, Inc. The
supplemental NADA provides for use of a milbemycin oxime/lufenuron
flavored tablet formulation for dogs not less than 4 weeks of age and
not less than 11 pounds of body weight for prevention of heartworm
disease, for prevention and control of flea populations, for control of
hookworm, and for removal and control of roundworms and whipworms.
EFFECTIVE DATE: August 3, 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
18300, Greensboro, NC 27419-8300, filed supplemental NADA 141-084 that
provides for veterinary prescription use of SentinelTM
(milbemycin oxime/lufenuron) flavor tablets (5.75 and 115 milligrams
(mg), 11.5 and 230 mg, and 23 and 460 mg) for dogs not less than 4
weeks of age and not less than 11 pounds of body weight. The tablets
are used for the prevention of heartworm disease, for prevention and
control of flea populations, for control of adult hookworm, and removal
and control of adult roundworm and whipworm infections when used at a
minimum dosage of 0.5 milligram/kilogram of body weight (mg/kg)
milbemycin with a minimum of 10 mg/kg lufenuron. The supplement is
approved as of June 17, 1998. To reflect the approval, FDA is
redesignating 21 CFR 520.1446(c) as paragraph (d), reserving paragraph
(c), and revising newly redesignated paragraph (d). The basis of
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
[[Page 41190]]
in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for
non-food producing animals qualifies for 3 years of marketing
exclusivity for the new formulation beginning June 17, 1998, because
the supplemental application contains substantial evidence of
effectiveness of the drug involved or any studies of animal safety
required for the approval of the supplement and conducted or sponsored
by the applicant. The 3 years of marketing exclusivity applies only to
use of the new milbemycin oxime/lufenuron flavored tablets in three
tablet sizes.
FDA 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 520.1446 is amended by redesignating paragraph (c) as
paragraph (d), by reserving paragraph (c), and by revising newly
redesignated paragraph (d), to read as follows:
Sec. 520.1446 Milbemycin oxime/lufenuron tablets.
* * * * *
(c) [Reserved]
(d) Conditions of use-- (1) Dogs-- (i) Amount. 0.5 milligrams of
milbemycin and 10 milligrams of lufenuron per kilogram of body weight.
(ii) Indications for use. For use in dogs and puppies for the
prevention of heartworm disease caused by Dirofilaria immitis, for
prevention and control of flea populations, control of adult
Ancylostoma caninum (hookworm), and removal and control of adult
Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis
(whipworm) infections. 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. Administer tablets once a month, preferably on
the same date each time. All dogs in a household should be treated to
achieve maximum efficacy. Do not use in dogs less than 4 weeks of age
and less than 2 pounds body weight. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(2) [Reserved]
Dated: July 14, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-20597 Filed 7-31-98 ; 8:45 am]
BILLING CODE 4160-01-F
