[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Rules and Regulations]
[Page 27733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Pimobendan

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 new animal drug application 
(NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides 
for the veterinary prescription use of pimobendan chewable tablets in 
dogs for the management of the signs of congestive heart failure.

DATES: This rule is effective May 17, 2007.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
N. Belt Hwy., St. Joseph, MO 64506-2002, filed NADA 141-273 that 
provides for the veterinary prescription use of VETMEDIN (pimobendan) 
Chewable Tablets in dogs for the management of the signs of mild, 
moderate, or severe (modified New York Heart Association Class II, III, 
or IV) congestive heart failure due to atrioventricular valvular 
insufficiency or dilated cardiomyopathy; for use with concurrent 
therapy for congestive heart failure as appropriate on a case-by-case 
basis. The NADA is approved as of April 30, 2007, and the regulations 
in 21 CFR part 520 are amended by adding Sec.  520.1780 to reflect the 
approval.
    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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning on the date of the approval.
    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.
    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.

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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. Add Sec.  520.1780 to read as follows:


Sec.  520.1780  Pimobendan.

    (a) Specifications. Each chewable tablet contains 1.25, 2.5, or 5 
milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body 
weight, using a suitable combination of whole or half tablets. The 
total daily dose should be divided into two portions administered 
approximately 12 hours apart.
    (2) Indications for use. For the management of the signs of mild, 
moderate, or severe (modified New York Heart Association Class II, III, 
or IV) congestive heart failure due to atrioventricular valvular 
insufficiency or dilated cardiomyopathy; for use with concurrent 
therapy for congestive heart failure as appropriate on a case-by-case 
basis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9516 Filed 5-16-07; 8:45 am]
BILLING CODE 4160-01-S