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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1780]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1780 Pimobendan.

(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.

(b) Sponsor. See No. 000010 in § 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.

[72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014]

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