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  1. Product Safety Information

Dear Pharmacy Professional Letter explaining the benefits of using AMODIP (amlodipine besylate tablets) for animal patients

October 6, 2026

Dear Pharmacy Professional:

On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved AMODIP (amlodipine besylate tablets) chewable tablets for use in cats. AMODIP is indicated for the control of systemic hypertension in cats. AMODIP is now being marketed.

Please be aware that any compounded animal drug, including a compounded amlodipine besylate 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.

Compounding from approved animal drugs such as AMODIP is permitted under specific conditions, when the source of the compounded drug is an FDA-approved dosage form. However, compounding animal drugs using bulk drug substances violates the Federal Food, Drug, and Cosmetic Act. CVM GFI #256, Compounding Animal Drugs from Bulk Drug Substances, describes the agency's compounding enforcement priorities and policies. Amlodipine besylate in all forms is on the Bulk Drug Substances Reviewed and Not Listed list, meaning it is not covered by the agency's enforcement discretion policy described in GFI #256 for the use of bulk drug substances to compound office stock.

Drug Information

AMODIP is a prescription animal drug containing amlodipine besylate in 1.25 mg scored chewable tablets and is supplied in packages of 3 blister cards of 10 tablets and 10 blister cards of 10 tablets. Please refer to the Freedom of Information Summary and package insert for AMODIP 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 established that:

  • The drug is safe and effective for a specific use in the intended 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.

The FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring 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 
 

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