[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Rules and Regulations]
[Pages 59003-59004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29631]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin With Pyrantel 
Pamoate

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 Merck Research Laboratories, Division of 
Merck & Co., Inc., for chewable tablets containing ivermectin with 
pyrantel pamoate. The product is used to prevent canine heartworm 
disease and to treat and control ascarid and hookworm

[[Page 59004]]

infections. The supplemental NADA provides for expanding the use for 
the treatment and control of an additional adult hookworm infection.

EFFECTIVE DATE: November 20, 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: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, filed supplemental 
NADA 140-971, which provides for the use of HeartgardTM Plus 
(ivermectin with pyrantel pamoate) in dogs for the treatment and 
control of adult hookworm Ancylostoma braziliense infections. The 
product is used to prevent canine heartworm disease by eliminating the 
tissue stage of heartworm larvae Dirofilaria immitis for 1 month (30 
days) after infection, and for the treatment and control of adult 
ascarids Toxocara canis and Toxascaris leonina, and adult hookworms A. 
caninum, Uncinaria stenocephala, and A. braziliense. The product is 
limited to use by or on the order of a licensed veterinarian. The 
supplement is approved as of October 3, 1996, and the regulations are 
amended in 21 CFR 520.1196(c)(1)(ii) to add treatment and control of 
adult hookworm A. braziliense. The basis of approval is discussed in 
the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, this supplemental NADA qualifies for a 3-year marketing 
exclusivity period beginning October 3, 1996, because it contains 
reports of new clinical or field investigations essential to the 
approval and conducted or sponsored by the applicant. The exclusivity 
period applies only to the added claim for treatment and control of 
adult hookworm A. braziliense.
    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 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. 520.1196   [Amended]

    2. Section 520.1196 Ivermectin and pyrantel pamoate chewable tablet 
is amended in paragraph (c)(1)(ii) by adding the name ``, A. 
braziliense,'' after ``Ancylostoma caninum''.

    Dated: October 29, 1996.
Andrew J. Beaulieau,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 96-29631 Filed 11-19-96; 8:45 am]
BILLING CODE 4160-01-F