21 CFR 516.1780

§ 516.1780 Pimobendan.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 516.1780, § 516.1780 Pimobendan, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87053
Permanent ID: ys:prov:87053@1
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Full text

(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—(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 in dogs. For the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (2019 ACVIM Consensus Statement). Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.