Issued: February 9, 2011
Reissued: March 3, 2016
Dear Equine Veterinarian:
In November 2010, FDA approved SUCROMATE Equine (deslorelin acetate, New Animal Drug Application 141-319) 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. SUCROMATE Equine is the only marketed FDA-approved animal drug that contains deslorelin as the active ingredient. FDA wants to remind you of the benefits of using approved drugs in your practice.
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. The concentration is 1.8 mg deslorelin acetate (1.7 mg deslorelin) per mL of suspension. Please refer to the Freedom of Information Summary and package insert for SUCROMATE Equine 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