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  5. Dear Veterinarian Letter advising veterinarians to use Vetmedin Solution (pimobendan oral solution) instead of unapproved drugs in their patients
  1. Product Safety Information

Dear Veterinarian Letter advising veterinarians to use Vetmedin Solution (pimobendan oral solution) instead of unapproved drugs in their patients

Dear Veterinarian:

In February 2024, the U.S. Food and Drug Administration (FDA) approved Vetmedin Solution (pimobendan oral solution) for use in dogs. The product is now being marketed.

Drug Information

Vetmedin Solution (pimobendan oral solution) is indicated 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). Vetmedin Solution is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Animal drugs containing pimobendan are also available in FDA-approved chewable dosage form.

Vetmedin Solution is a prescription animal drug containing 1.5 mg pimobendan/mL and is supplied in a 60 mL bottle containing 50 mL solution. It comes with its own syringe calibrated for dosing based on the dog’s weight. Please refer to the Freedom of Information Summary and package insert for Vetmedin Solution for more information. 

FDA-approved drugs have been demonstrated to be safe and effective for their intended use and are required to comply with Current Good Manufacturing Practice (CGMP) that assures the drugs’ identity, strength, quality (including potency and sterility), and purity. When pimobendan oral solution is indicated for use in a patient, the FDA strongly encourages veterinarians to use the FDA-approved Vetmedin Solution. As with all approved animal drugs, the FDA will monitor and routinely evaluate post market safety information submitted for Vetmedin Solution, which includes monitoring adverse event reports for potential human or animal safety risks associated with administration of the drug. 

Benefits of FDA Approval

The FDA wants to remind you of the benefits of FDA approval. Animal drugs are rigorously evaluated by the FDA before approving them. As part of the FDA approval process, the drug company establishes that:

  • The drug is safe and effective for a specific use in a specific animal species; 
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and not misleading.

The FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:

  • The drug’s safety and effectiveness; 
  • The manufacturing process to ensure that the identity, strength, quality, and purity of the drug are maintained;
  • The drug’s labeling to make sure the information remains truthful and not misleading; and
  • The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.

Safety and Effectiveness of Vetmedin Solution Compared to Compounded Forms of Pimobendan 

Animal drugs compounded from bulk drug substances are not FDA-approved drugs (pioneer or generic). The absorption and bioavailability of compounded formulations of pimobendan are unknown and may be inadequate or variable. Unlike FDA-approved Vetmedin Solution, compounded and other unapproved formulations of pimobendan have not been evaluated by the FDA for safety or effectiveness and may vary in quality, potency, and bioavailability.

There are many post-approval requirements for sponsors of FDA-approved animal drugs, including the mandatory reporting of adverse drug experience reports; there are no such mandatory reporting requirements for compounded animal drugs.  The FDA encourages veterinarians and animal owners to report adverse drug experiences and product defects associated with animal drugs, regardless of whether they are FDA-approved.  More information about how to report information about animal drugs and devices can be found at our website: www.fda.gov/reportanimalae.

The agency is aware that pimobendan oral solutions compounded from bulk drug substances may be available through some compounding pharmacies. Pimobendan oral suspension and oral solution are both on the Bulk Drug Substances Reviewed and Not Listed list, meaning they are not covered by the agency’s enforcement discretion policy covering the use of bulk drug substances to compound office stock described in CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances.  Unapproved pimobendan products should not be imported from other countries for use in animal patients.

The FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring marketed animal drugs are safe and effective.  For more information, please contact AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine
 

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