Dear Equine Veterinarian:
In November 2010, FDA approved SUCROMATE Equine (deslorelin acetate) for inducing ovulation within 48 hours of treatment in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter. Mares are treated once per estrus cycle with an intramuscular injection in the neck, given 48 hours before desired ovulation. Two animal drugs that contain deslorelin as the active ingredient are FDA-approved for use in mares; however, SUCROMATE Equine is the only one currently marketed.
Manufactured by Thorn BioScience LLC, SUCROMATE Equine is a prescription drug available in the U.S. as an injectable, sustained-release suspension that comes in a 10-dose vial (New Animal Drug Application 141-319). The concentration is 1.8 mg deslorelin acetate (1.7 mg deslorelin) per mL of suspension. Please refer to Animal Drugs @ FDA for more information about SUCROMATE Equine. FDA wants to remind you of the benefits of using approved drugs in your practice.
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. The company must show that the drug can be consistently produced from batch to batch; and
- The drug’s labeling is truthful, complete, and not misleading. The company must make sure that the labeling contains all the necessary information to use the drug safely and effectively and includes the risks associated with the drug.
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 from batch to batch;
- The drug’s labeling to make sure the information remains truthful, complete, 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