[Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)]
[Rules and Regulations]
[Pages 50096-50097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24160]
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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
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 supplemental new animal drug
application (NADA) filed by Ciba-Geigy Animal Health, Ciba-Geigy Corp.
The supplemental NADA provides for the use of milbemycin oxime tablets
in puppies 4 weeks of age or greater and 2 pounds (lb) of body weight
or greater for the prevention of heartworm disease, control of adult
hookworm infections, and removal and control of adult roundworm and
whipworm infections.
EFFECTIVE DATE: September 28, 1995.
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: Ciba-Geigy Animal Health, Ciba-Geigy Corp.,
P.O. Box 18300, Greensboro, NC 27419-8300, filed a supplement to NADA
140-915 for INTERCEPTOR (milbemycin oxime) tablets. The NADA
provides for veterinary prescription use of 2.3-,
5.75-, 11.5-, and 23.0-milligrams INTERCEPTOR tablets for
use as an anthelmintic in dogs in the prevention of heartworm disease
caused by Dirofilaria immitis, control of adult Ancylostoma caninum
(hookworm), removal and control of adult Toxocara canis (roundworm),
and Trichuris vulpis (whipworm) infections in dogs. The supplement
provides for use of the product to treat puppies 4 weeks of age or
greater and 2 lb of body weight or greater for the same infections.
The supplemental NADA 140-915 is approved as of August 16, 1995,
and the regulations are amended by revising 21 CFR 520.1445(c)(2) and
(c)(3) to reflect
[[Page 50097]]
the approval. The basis of approval is discussed in the freedom of
information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity for the new indications
beginning August 16, 1995, because new clinical or field investigations
(other than bioequivalence or residue studies) conducted by the sponsor
were required for the approval.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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).
Sec. 520.1445 [Amended]
2. Section 520.1445 Milbemycin oxime tablets is amended in
paragraph (c)(2) by adding the phrase ``and in puppies 4 weeks of age
or greater and 2 pounds of body weight or greater.'' at the end of the
paragraph and in paragraph (c)(3) by adding the sentence ``Do not use
in puppies less than 4 weeks of age and less than 2 pounds in body
weight.'' at the beginning of the paragraph.
Dated: September 15, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-24160 Filed 9-27-95; 8:45 am]
BILLING CODE 4160-01-F
