[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39867-39868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19410]


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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 Tables and Chewable 
Cubes

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 two supplemental new animal 
drug applications (NADA's) filed by Merck Research Laboratories, 
Division of Merck & Co., Inc. The supplemental NADA's provide for label 
changes including a revised indication and limitation for oral use of 
ivermectin tablets and chewable cubes for dogs to prevent canine 
heartworm disease.

EFFECTIVE DATE: July 31, 1996.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0137.

SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, filed supplemental 
NADA's 138-412 and 140-886, which provide for use of 
Heartgard (ivermectin) Tablets and Heartgard 
(ivermectin) Chewables for dogs. The supplemental NADA's amend the 
approved indications for use to read ``To prevent canine heartworm 
disease by eliminating the tissue stage of heartworm larvae 
(Dirofilaria immitis) for 1 month (30 days) after infection.'' The 
supplements also amend the limitations pertaining to puppies to state 
``Recommended for dogs 6 weeks of age and older.'' These changes are 
necessary to be consistent with the labeling for Heartgard-30 
Plus (ivermectin and pyrantel pamoate) NADA 140-971, as published in 
the Federal Register of April 15, 1996 (61 FR 15185 at 15186). The 
supplemental NADA's 138-412 and 140-886 are approved as of June 14, 
1996, and the regulations are amended in 21 CFR 520.1193(c)(2) and 
(c)(3) to reflect the approval.
     Approval of these supplements did not require submission of new 
data and information. Therefore, freedom of information summaries under 
part 20 (21 CFR part 20) and 21 CFR 514.11(e)(2)(ii) are not required.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals do not 
qualify for marketing exclusivity because the supplements do not 
contain reports of new clinical or field investigations (other than 
bioequivalence or residue studies) essential to the approvals and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

[[Page 39868]]

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 520.1193 is amended by revising paragraphs (c)(2) and 
(c)(3) to read as follows:


Sec. 520.1193  Ivermectin tablets and chewable cubes.

* * * * *
    (c) * * *
    (2) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection.
    (3) Limitations. Use once-a-month. Recommended for dogs 6 weeks of 
age and older. Initial use within 1 month after first exposure to 
mosquitoes. Final use within 1 month after last exposure to mosquitoes. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: June 9, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-19410 Filed 7-30-96; 8:45 am]
BILLING CODE 4160-01-F