21 C.F.R. § 520.1782

Current through October 31, 2024
Section 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 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.

21 C.F.R. §520.1782

89 FR 42357 , May 15, 2024
89 FR 42357 , 5/15/2024