[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Page 54018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22043]
[[Page 54018]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel
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 Bayer HealthCare LLC. The supplement
provides for two new sizes of praziquantel and pyrantel pamoate tablets
used in cats and kittens for the removal of various internal parasites
and for a revised kitten age and weight restriction.
DATES: This rule is effective September 3, 2010.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, email:
[email protected].
SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141-008 for DRONTAL (praziquantel and pyrantel pamoate) Tablets
used in cats and kittens for the removal of various internal parasites.
The supplement provides for two new tablet sizes and for a revised
kitten age and weight restriction. The supplemental NADA is approved as
of June 15, 2010, and 21 CFR 520.1871 is amended to reflect the
approval.
FDA has determined under 21 CFR 25.33 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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
0
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 520.1871, in paragraph (b)(1), remove ``tablet'' and in its
place add ``tablets''; and revise paragraphs (a)(1), (d)(1)(i), and
(d)(1)(iii) to read as follows:
Sec. 520.1871 Praziquantel and pyrantel.
(a) * * *
(1) Each tablet contains 13.6 milligrams (mg) praziquantel and 54.3
mg pyrantel base (as pyrantel pamoate), 18.2 mg praziquantel and 72.6
mg pyrantel base (as pyrantel pamoate), or 27.2 mg praziquantel and
108.6 mg pyrantel base (as pyrantel pamoate).
* * * * *
(d) * * *
(1) * * *
(i) Dosage. Administer a minimum dose of 2.27 mg praziquantel and
9.2 mg pyrantel pamoate per pound of body weight according to the
dosing tables on labeling. May be given directly by mouth or in a small
amount of food. Do not withhold food prior to or after treatment. If
reinfection occurs, treatment may be repeated.
* * * * *
(iii) Limitations. Not for use in kittens less than 2 months of age
or weighing less than 2.0 pounds. Consult your veterinarian before
giving to sick or pregnant animals.
* * * * *
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22043 Filed 9-2-10; 8:45 am]
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