U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Animal & Veterinary
  3. Safety & Health
  4. Product Safety Information
  5. Dear Pharmacy Professional Letter advising pharmacies to dispense Vetmedin Solution (pimobendan oral solution) instead of unapproved drugs for animal patients
  1. Product Safety Information

Dear Pharmacy Professional Letter advising pharmacies to dispense Vetmedin Solution (pimobendan oral solution) instead of unapproved drugs for animal patients

Dear Pharmacy Professional:

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

Please be aware that any compounded animal drug, including a compounded pimobendan product is not FDA-approved. This means the FDA has not evaluated the safety and effectiveness of the compounded drug or the adequacy of the manufacturing process. 
Drugs compounded from bulk drug substances also violate the Federal Food, Drug, and Cosmetic Act. CVM GFI #256, Compounding Animal Drugs from Bulk Drug Substances, describes our compounding enforcement priorities and policies.  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.  We remind pharmacies that, if they receive patient-specific prescriptions for compounded drugs containing pimobendan, they should use FDA-approved products (such as Vetmedin Solution) as the source of pimobendan when possible, as described in GFI #256.  Unapproved pimobendan products should not be imported from other countries for use in animal patients. 

Drug Information

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.

Benefits of FDA Approval

The FDA rigorously evaluates an animal drug before approving it. 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, including sterility and potency, 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.

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.  If you have any questions or comments, please contact AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine
 

Back to Top