[Federal Register Volume 64, Number 132 (Monday, July 12, 1999)]
[Rules and Regulations]
[Pages 37400-37401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin

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 Pfizer, Inc. The NADA provides for veterinary 
prescription use of selamectin solution as a topical parasiticide for 
dogs and cats.

EFFECTIVE DATE: July 12, 1999.

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.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed NADA 141-152 that provides for topical veterinary 
prescription use of RevolutionTM (selamectin) solution. 
Selamectin kills adult fleas and prevents flea eggs from hatching for 1 
month, and it is indicated for the prevention and control of flea 
infestations (Ctenocephalides felis), prevention of heartworm disease 
caused by Dirofilaria immitis, and treatment and control of ear mite 
(Otodectes cynotis) infestations in dogs and cats; in dogs for 
treatment and control of sarcoptic mange (Sarcoptes scabiei); and in 
cats for treatment of intestinal hookworm (Ancylostoma tubaeforme) and 
roundworm (Toxocara cati) infections. The NADA is approved as of May 
26, 1999, and the regulations are amended by adding 21 CFR 524.2098 to 
reflect the approval.
    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 section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning May 26, 1999, 
because no active ingredient (including any ester or salt of the drug) 
has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    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.
    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.

[[Page 37401]]

List of Subjects in 21 CFR Part 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

    2. Section 524.2098 is added to read as follows:

Sec. 524.2098  Selamectin.

    (a) Specifications. Each milliliter contains 60 or 120 milligrams 
of selamectin.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 2.7 milligrams of selamectin, 
topically, per pound (6 milligrams per kilogram) of body weight once a 
month.
    (2) Indications for use. Kills adult fleas and prevents flea eggs 
from hatching for 1 month, and it is indicated for the prevention and 
control of flea infestations (Ctenocephalides felis), prevention of 
heartworm disease caused by Dirofilaria immitis, and treatment and 
control of ear mite (Otodectes cynotis) infestations in dogs and cats. 
Treatment and control of sarcoptic mange (Sarcoptes scabiei) in dogs. 
Treatment of intestinal hookworm (Ancylostoma tubaeforme) and roundworm 
(Toxocara cati) infections in cats. For dogs and cats 6 weeks of age 
and older.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: June 29, 1999.
 George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-17507 Filed 7-9-99; 8:45 am]
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