Animal drugs, feeds, and related products: New drug applications— Milbemycin oxime/lufenuron tablets,

[Federal Register: August 3, 1998 (Volume 63, Number 148)]

[Rules and Regulations]

[Page 41189-41190]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr03au98-10]

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.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filedby 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, filedsupplemental NADA 141-084 that provides for veterinary prescription use of Sentinel‹SUP›TM‹/SUP› (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. 98-20597Filed7-31-98; 8:45 am]

   BILLING CODE 4160-01-F