[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
