[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15185-15186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8362]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 a chewable tablet containing ivermectin in
combination with pyrantel pamoate. The product is used to prevent
canine heartworm disease and to treat and control ascarid and hookworm
infections in dogs. The supplemental NADA provides for extending the
use in dogs to those weighing less than 5 pounds and for revising the
limitation in the regulation concerning use in dogs under 6 weeks of
age.
EFFECTIVE DATE: April 5, 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 extending the use of Heartgard-
30 Plus (ivermectin with pyrantel pamoate) to dogs weighing
less than 5 pounds. In addition, the limitation in the regulation,
``Not to be used in dogs under 6 weeks of age.'', is being corrected to
read ``Recommended for dogs 6 weeks of age and older.'' The product is
used to prevent canine heartworm disease by eliminating the tissue
larval stages of Dirofilaria immitis for 30 days after infection, and
for the treatment and control of adult ascarids Toxocara canis and
Toxascaris leonina, and adult hookworms Ancylostoma
[[Page 15186]]
caninum and Uncinaria stenocephala. The supplement is approved as of
February 15, 1996, and the regulations are amended in Sec. 520.1196 (21
CFR 520.1196) by revising the limitation in paragraph (c)(1)(iii) as
above to reflect the correct limitation as is stated in the approved
product labeling. The basis of approval is discussed in the freedom of
information summary.
In addition, the heading of Sec. 520.1196 is revised from
``pyrantel (as pamoate salt)'' to ``pyrantel pamoate'' in order to
conform with titles of other sections.
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, this supplemental NADA qualifies for a 3-year marketing
exclusivity period beginning February 15, 1996, because new clinical or
field investigations (other than bioequivalence or residue studies)
essential to the approval were conducted or sponsored by the applicant.
The exclusivity period applies only to use in animals weighing less
than 5 pounds.
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).
2. Section 520.1196 is amended by revising the section heading and
in paragraph (c)(1)(iii) by revising the second sentence to read as
follows:
Sec. 520.1196 Ivermectin and pyrantel pamoate chewable tablet.
* * * * *
(c) * * *
(1) * * *
(iii) * * * Recommended for dogs 6 weeks of age and older. * * *
* * * * *
Dated: March 28, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-8362 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F
