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  5. Dear Pharmacy Professional Letter advising pharmacies to dispense Bimasone (flumethasone injection) instead of unapproved drugs for animal patients
  1. Product Safety Information

Dear Pharmacy Professional Letter advising pharmacies to dispense Bimasone (flumethasone injection) instead of unapproved drugs for animal patients

July 10, 2024

Dear Pharmacy Professional:

In April 2023, the U.S. Food and Drug Administration approved Bimasone (flumethasone injectable solution) for use in horses, dogs, and cats for the various rheumatic, allergic, dermatologic, and other disease states which are known to be responsive to the anti-inflammatory corticoids. Bimasone is the first generic flumethasone product to receive FDA approval and is now being marketed. Flucort Solution was first approved for use in horses, dogs, and cats on October 21, 1965, and is no longer marketed.

Unapproved flumethasone products should not be imported from other countries for use in animal patients. Also, please be aware that any compounded animal drug, including a compounded flumethasone 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. See Guidance for Industry CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances for more information on the FDA’s current enforcement policy.

Drug Information

Bimasone is a prescription animal drug containing 0.5 mg flumethasone/mL and is supplied in 100 mL multi-dose vials. Please refer to the Freedom of Information Summary and package insert for Bimasone for more information.

Benefits of FDA Approval

The FDA rigorously evaluates a generic animal drug before approving it. As part of the approval process, the drug company must prove to the FDA that:

  • There are data to support that the drug is bioequivalent to the FDA-approved name brand (reference-listed) drug. This means that the drug is expected to act the same way in the animal; and therefore, it is presumed safe and effective for a specific use in the intended 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 safe and effective drugs are available for animals. If you have any questions or comments, please contact AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine
 

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