[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)]
[Rules and Regulations]
[Page 43654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21728]
[[Page 43654]]
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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 expanding the indications for use of
milbemycin oxime tablets in dogs and puppies to include removal and
control of adult roundworm infections caused by Toxascaris leonina.
EFFECTIVE DATE: August 26, 1996.
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, is the sponsor of NADA 140-
915, which covers Interceptor (milbemycin oxime) tablets. The
product is currently approved for the prevention of heartworm disease
caused by Dirofilaria immitis, control of hookworm infections caused by
Ancylostoma caninum, and removal and control of adult roundworm
infections caused by Toxocara canis and whipworm infections caused by
Trichuris vulpis in dogs and in puppies 4 weeks of age or greater and 2
pounds of body weight or greater. The supplemental NADA provides for
expanding the indications for use in both dogs and puppies by adding
removal and control of the adult roundworm T. leonina. The drug is
available by veterinary prescription.
The supplemental NADA 140-915 is approved as of July 9, 1996, and
the regulations are amended in 21 CFR 520.1445(c)(2) to reflect 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, 12420
Parklawn Dr., rm. 1-23, 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 approval qualifies
for 3 years of marketing exclusivity for the new indications beginning
on July 9,1996, because the application includes reports of new
clinical or field investigations (other than bioequivalence or residue
studies) essential to the approval and conducted by the sponsor.
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
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 Toxascaris leonina'' after
``Toxocara canis''.
Dated: August 14, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-21728 Filed 8-23-96; 8:45 am]
BILLING CODE 4160-01-F
