[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Rules and Regulations]
[Pages 41188-41189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20533]


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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 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 lower dose of milbemycin oxime 
in treating dogs and puppies for the prevention of heartworm disease.

EFFECTIVE DATE: August 3, 1998.

[[Page 41189]]

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 140-915 that 
provides for veterinary prescription use of 2.3- and 5.75-milligram 
(mg) SAFEHEART<SUP>TM</SUP> (milbemycin oxime) tablets in dogs and 
puppies 4 weeks of age or older and 2 pounds (lb) body weight or 
greater for the prevention of heartworm disease caused by Dirofilaria 
immitis at a minimum dosage of 0.1 mg milbemycin oxime/kilogram (kg) of 
body weight (0.05 mg/lb). The supplement is approved as of June 4, 
1998. FDA is amending the regulations in 21 CFR 520.1445(c) and (d) to 
reflect the approval. 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 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 beginning June 4, 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 milbemycin oxime 
tablets at 0.1 mg/kg for prevention of canine heartworm disease.
    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 520.1445 is amended by removing and reserving paragraph 
(c) and by revising paragraph (d) to read as follows:


Sec. 520.1445  Milbemycin oxime tablets.

* * * * *
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs and puppies--(i) Amount. For 
hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body 
weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram 
per pound of body weight (0.1 milligram per kilogram).
    (ii) Indications for use. For prevention of heartworm disease 
caused by Dirofilaria immitis, control of hookworm infections caused by 
Ancylostoma caninum, and removal and control of adult roundworm 
infections caused by Toxocara canis and Toxascaris leonina and whipworm 
infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of 
age or greater and 2 pounds of body weight or greater.
    (iii) Limitations. Do not use in puppies less than 4 weeks of age 
and less than 2 pounds of body weight. Administer once a month. First 
dose given within 1 month after first exposure to mosquitoes and 
continue regular use until at least 1 month after end of mosquito 
season. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Cats and kittens--(i) Amount. 0.91 milligram per pound of body 
weight (2.0 milligrams per kilogram).
    (ii) Indications for use. For prevention of heartworm disease 
caused by Dirofilaria immitis and the removal of adult Toxocara cati 
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 
weeks of age or greater and 1.5 pounds body weight or greater.
    (iii) Limitations. Do not use in kittens less than 6 weeks of age 
or 1.5 pounds body weight. Administer once a month. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: July 10, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-20533 Filed 7-31-98; 8:45 am]
BILLING CODE 4160-01-F