[Federal Register Volume 63, Number 103 (Friday, May 29, 1998)]
[Rules and Regulations]
[Pages 29351-29352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14182]
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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 Tablet
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 Novartis Animal Health US, Inc. The
supplemental NADA provides for expanding the indications to include
separate dosage and labeling for use of milbemycin oxime in cats.
EFFECTIVE DATE: May 29, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., P.O. Box
26402, Greensboro, NC 27404-6402, filed supplemental NADA 140-915 that
provides for oral administration of Interceptor Flavor
Tabs (milbemycin oxime) tablets to cats 6 weeks of age or
greater and 1.5 pounds of body weight or greater. The product is
currently approved for the prevention of heartworm disease in both dogs
and puppies 4 weeks of age or greater. The supplemental NADA provides
for expanding the indications to include separate dosage and labeling
for use of
[[Page 29352]]
the product in cats 6 weeks of age or greater and 1.5 pounds of body
weight or greater. This supplemental NADA approval provides for 5.75,
11.5, and 23.0 milligram tablets, given orally, once a month, for the
prevention of heartworm disease caused by Dirofilaria immitis and the
removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme
(hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds
body weight or greater. The supplemental NADA is approved as of April
13, 1998, and the regulations are amended in 21 CFR 520.1445 by
revising paragraph (a) and the heading of paragraph (c) and by adding
paragraph (d) to reflect the approval for cats. The basis for approval
is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 beginning April 13, 1998, because
the application contains substantial evidence of effectiveness of the
drug involved and studies of animal safety required for approval and
conducted or sponsored by the applicant.
The agency has determined under 21 CFR 25.33(d)(1) 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.
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: 21 U.S.C. 360b.
2. Section 520.1445 is amended by revising paragraph (a) and the
heading of paragraph (c) and by adding paragraph (d) to read as
follows:
Sec. 520.1445 Milbemycin oxime tablets.
(a) Specifications--(1) Dogs. Each tablet contains 2.3, 5.75, 11.5,
or 23.0 milligrams of milbemycin oxime.
(2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligrams of
milbemycin oxime.
* * * * *
(c) Conditions of use in dogs. * * *
(d) Conditions of use in cats--(l) Amount. 0.91 milligram per pound
of body weight (2.0 milligrams per kilogram).
(2) Indications for use. For prevention of heartworm disease
caused by Dirofilaria immitis and the removal of adult Toxocara cati
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6
weeks of age or greater and 1.5 pounds body weight or greater.
(3) Limitations. Do not use in kittens less than 6 weeks of age or
1.5 pounds body weight. Administer once a month. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Dated: May 11, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-14182 Filed 5-28-98; 8:45 am]
BILLING CODE 4160-01-F
