Issued: December 3, 2010
Reissued: March 2, 2016
Dear Equine Veterinarian:
In September 2010, FDA approved EQUIDONE (domperidone, New Animal Drug Application 141-314) Gel to prevent fescue toxicosis in periparturient mares. At-risk mares are treated with EQUIDONE Gel once daily starting 10 to 15 days before their expected foaling dates. They may continue to be treated up to 5 days after foaling. EQUIDONE Gel is the first, and so far only, FDA-approved animal drug that contains domperidone as the active ingredient. FDA wants to remind you of the benefits of using approved drugs in your practice.
Distributed by Dechra Ltd., EQUIDONE Gel is a prescription drug available in the U.S. as an oral gel that comes in disposable 25 cc multi-dose syringes. The concentration is 110 mg domperidone per cc of gel. Please refer to the Freedom of Information Summary and package insert for EQUIDONE Gel for more information about the drug.
Benefits of FDA Approval
FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA 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.
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. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
- The manufacturing process to ensure quality and consistency 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.
FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring that safe and effective drugs are available for animals. For more information, please contact CVM’s Education & Outreach Staff at 240-402-7002 or AskCVM@fda.hhs.gov.
FDA’s Center for Veterinary Medicine