[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Rules and Regulations]
[Pages 28628-28629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13823]


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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 new animal drug application 
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for 
use of milbemycin oxime/lufenuron tablets for prevention of heartworm 
disease caused by Dirofilaria immitis, control of adult Ancylostoma 
caninum, the removal and control of adult Toxocara canis, Toxascaris 
leonina, and Trichuris vulpis infections, and the prevention and 
control of flea populations in dogs.

EFFECTIVE DATE: May 27, 1997.

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: Novartis Animal Health US, Inc., P.O. Box 
18300, Greensboro, NC 27419-8300, filed NADA 141-084, which provides 
for oral administration of SENTINELTM (milbemycin oxime/
lufenuron) tablets containing 2.3 milligrams (mg) milbemycin oxime/46 
mg lufenuron, 5.75 mg/115 mg, 11.5 mg/230 mg, or 23 mg/460 mg per 
tablet. SENTINELTM tablets are administered once a month to 
dogs, 4 weeks of age and older and 2 pounds body weight or greater, for 
the prevention of heartworm disease caused by D. immitis, for the 
prevention and

[[Page 28629]]

control of flea populations, the control of adult A. caninum 
(hookworm), and the removal and control of adult T. canis and T. 
leonina (roundworm), and T. vulpis (whipworm) infections. The NADA is 
approved as of April 10, 1997, and the regulations are amended in part 
520 (21 CFR part 520) by adding new Sec. 520.1446 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
a 3-year period of exclusivity beginning April 10, 1997, because the 
application contains substantial evidence of the effectiveness of the 
drugs involved, and studies of animal safety, required for approval of 
the application and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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. New Sec. 520.1446 is added to read as follows:

Sec. 520.1446 Milbemcyin oxime/lufenuron tablets.

     (a) Specifications. Tablets containing: 2.3 milligrams milbemycin 
oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 
milligrams/230 milligrams, and 23 milligrams/460 milligrams.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.5 milligrams of milbemycin and 
10 milligrams of lufenuron per kilogram of body weight.
    (2) Indications for use. For use in dogs, 4 weeks of age and older 
and 2 pounds body weight or greater, for the prevention of heartworm 
disease caused by Dirofilaria immitis, for the prevention and control 
of flea populations, the control of adult Ancylostoma caninum 
(hookworm), and the removal and control of adult Toxocara canis, 
Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) 
infections.
    (3) Limitations. Administer tablet(s) once a month, preferably on 
same date each time. All dogs in a household should be treated to 
achieve maximum efficacy. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

    Dated: May 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-13823 Filed 5-23-97; 8:45 am]
BILLING CODE 4160-01-F