[Federal Register Volume 68, Number 168 (Friday, August 29, 2003)]
[Rules and Regulations]
[Pages 51904-51906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22072]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lufenuron Tablets; Milbemycin 
Oxime and Lufenuron Tablets; Nitenpyram 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 two original new animal drug 
applications (NADAs) and three supplemental NADAs filed by Novartis 
Animal Health US, Inc. The original NADAs provide for the concurrent 
oral use in dogs of approved milbemycin oxime and lufenuron flavor 
tablets with nitenpyram tablets to kill adult fleas and

[[Page 51905]]

prevent flea eggs from hatching and for the concurrent oral use in dogs 
and cats of approved lufenuron flavor tablets with nitenpyram tablets 
to kill adult fleas and prevent flea eggs from hatching. The 
supplemental NADAs provide appropriate labeling for the concurrent uses 
of the individual products and, for lufenuron flavor tablets, use in 
puppies and kittens as young as 4 weeks of age.

DATES: This rule is effective August 29, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-204 for 
the concurrent use in dogs of their SENTINEL (milbemycin oxime and 
lufenuron ) FLAVOR TABS, approved under NADA 141-084, with their 
CAPSTAR (nitenpyram) Tablets, approved under NADA 141-175, to kill 
adult fleas and prevent flea eggs from hatching. Novartis Animal Health 
US also filed NADA 141-205 for the concurrent use in dogs and cats of 
their PROGRAM (lufenuron) FLAVOR TABS, approved under NADA 141-035, 
with CAPSTAR Tablets to kill adult fleas and prevent flea eggs from 
hatching. Supplemental NADAs were also filed to NADA 141-035, NADA 141-
084, and NADA 141-175 to provide appropriate labeling for the 
concurrent uses of these products under NADA 141-204 and NADA 141-205, 
and to NADA 141-035 for use of lufenuron flavor tablets in puppies and 
kittens as young as four weeks of age. The NADAs and supplemental NADAs 
are approved as of, June 11, 2003, and the regulations are amended in 
21 CFR 520.1288, 520.1446, and 520.1510 to reflect the approval. The 
basis of approval is discussed in the freedom of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 sections 512(c)(2)(F)(ii) or (iii) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii) or (iii)), 
these NADAs and supplemental NADAs qualify for 3 years of marketing 
exclusivity beginning Jue 11, 2003.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither 
environmental assessments nor environmental impact statements are 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801 808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Section 520.1288 is revised to read as follows:


Sec.  520.1288  Lufenuron tablets.

    (a) Specifications--(1) Tablets containing 45, 90, 204.9, or 409.8 
milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), 
(c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) 
of this section.
    (2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams 
(mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or 
(c)(1)(ii)(B), and (c)(1)(iii) of this section.
    (3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and 
(c)(2)(iii) of this section.
    (4) Flavored tablets containing 135 or 270 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this 
section.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Minimum of 10 mg 
lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a 
month.
    (ii) Indications for use--(A) For the prevention and control of 
flea populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this 
section with nitenpyram tablets as in Sec.  520.1510(d)(1) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in dogs and puppies 4 weeks of age and 
older.
    (2) Cats--(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 
mg/lb) of body weight, once a month.
    (ii) Indications for use--(A) For the control of flea populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this 
section with nitenpyram tablets as in Sec.  520.1510(d)(2) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in cats and kittens 4 weeks of age and 
older.
0
3. Section 520.1446 is amended by revising the section heading, 
paragraphs (a), (d)(1)(i), (d)(1)(ii), and (d)(1)(iii) to read as 
follows:


Sec.  520.1446  Milbemycin oxime and lufenuron tablets.

    (a) Specifications--(1) Tablets containing: 2.3 milligrams (mg) 
milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 
mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg 
milbemycin oxime and 460 mg lufenuron.
    (2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg 
lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg 
milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 
460 mg lufenuron.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. 0.5 mg milbemycin oxime and 10 mg lufenuron per 
kilogram of body weight, once a month.
    (ii) Indications for use--(A) For use in dogs and puppies for the 
prevention of heartworm disease caused by Dirofilaria immitis, for 
prevention and control of flea populations, for control of adult 
Ancylostoma caninum (hookworm), and for removal and control of adult 
Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis 
(whipworm) infections.
    (B) The concurrent use of flavored milbemycin oxime and lufenuron 
tablets described in paragraph (a)(2) of this section as in paragraph 
(d)(1)(ii)(A) of this section with nitenpyram tablets as in Sec.  
520.1510(d)(1) of this chapter is indicated to kill adult fleas and 
prevent flea eggs from hatching.

[[Page 51906]]

    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

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4. Section 520.1510 is revised to read as follows:


Sec.  520.1510  Nitenpyram tablets.

    (a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) 
nitenpyram.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. The concurrent use of nitenpyram 
tablets and flavored milbemycin/lufenuron tablets as in paragraph 
(d)(1)(ii)(B) of this section shall be by or on the order of a licensed 
veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount--(A) One 11.4-mg tablet 
for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs 
weighing more than 25 lb, as needed, for use as in paragraph 
(d)(1)(ii)(A) of this section.
    (B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 
mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for 
use as in paragraph (d)(1)(ii)(B) of this section.
    (ii) Indications for use--(A) For the treatment of flea 
infestations on dogs and puppies 4 weeks of age and older and 2 lbs of 
body weight or greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(1)(i)(B) of this section with either flavored lufenuron tablets as 
in Sec.  520.1288(c)(1) of this chapter or flavored milbemycin and 
lufenuron tablets as in Sec.  520.1446(d)(1) of this chapter is 
indicated to kill adult fleas and prevent flea eggs from hatching.
    (2) Cats--(i) Amount--(A) One 11.4-mg tablet, as needed, for use as 
in paragraph (d)(2)(ii)(A) of this section.
    (B) One 11.4-mg tablet, once or twice weekly, for use as in 
paragraph (d)(2)(ii)(B) of this section.
    (ii) Indications for use--(A) For the treatment of flea 
infestations on cats and kittens 4 weeks of age and older and 2 lbs of 
body weight or greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(2)(i)(B) of this section with flavored lufenuron tablets as in 
Sec.  520.1288(c)(2) of this chapter is indicated to kill adult fleas 
and prevent flea eggs from hatching.

    Dated: August 18, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-22072 Filed 8-28-03; 8:45 am]
BILLING CODE 4160-01-S