[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]
BILLING CODE 4160-01-F
