21 CFR § 520.1780 - Pimobendan tablets.

---
identifier: "/us/cfr/t21/s520.1780"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1780 - Pimobendan tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1780"
section_name: "Pimobendan tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1780 Pimobendan tablets.

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

(b) *Sponsors.* See Nos. 000010 and 069043 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 congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (*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.

[72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014; 87 FR 10968, Feb. 28, 2022; 89 FR 42357, May 15, 2024; 89 FR 85426, Oct. 28, 2024]