Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 520.1782: Pimobendan solution.

(a) Specifications. Each milliliter of solution contains 1.5 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/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart (i.e., morning and evening).
(2) Indications for use. For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for CHF (e.g., furosemide, etc.) 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.

Where this section sits in the code

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

(a) Specifications. Each milliliter of solution contains 1.5 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/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart (i.e., morning and evening).

(2) Indications for use. For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for CHF (e.g., furosemide, etc.) 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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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