FDA Warns About Compounded Use Of Deslorelin Now That SucroMate Equine Is Approved
The U.S. Food and Drug Administration sent a letter to veterinarians today reminding them that now SucroMate Equine is approved and available for veterinary use in the United States, deslorelin should not be imported from other countries or compounded from bulk.
SucroMate Equine is the only marketed FDA-approved animal drug that contains deslorelin as the active ingredient.
The drug, manufactured by Thorn BioScience, was approved in November 2010 as a way to regulate ovulation in mares. The injectable, sustained-release suspension is said to increase the likelihood of conception during breeding for both natural bred and artificially inseminated horses.
The suspension comes in a 10 mL vial that can be used for 10 doses. The strength is 1.8 mg deslorelin acetate per mL.
The FDA’s letter to veterinarians outlines its “rigorous” drug evaluation process. It also emphasizes that animal drugs compounded from bulk do not go through this process.
“An animal drug that is compounded from bulk drug ingredients is not FDA-approved,” the FDA said in its letter. “This means FDA has not evaluated the safety and effectiveness of the compounded drug or the adequacy of the manufacturing process.
“In prescribing FDA-approved SucroMate Equine to induce ovulation, you are providing your clients and their mares with the only marketed deslorelin product shown to be safe and effective in horses. Also, SucroMate Equine is the only marketed deslorelin product that is manufactured to meet FDA’s strict standards for quality, purity and potency.”
The FDA noted that some veterinarians may have patients that require deslorelin in strengths or forms that are not offered by SucroMate Equine. In such cases, deslorelin can only be legally compounded by using FDA-approved SucroMate Equine as the starting material, according to the FDA.
The FDA sent out a similar letter to pharmacies.
“There may be instances where you may be asked to compound deslorelin for specific patients that require the drug in strengths or forms that are not offered by SucroMate Equine,” the FDA wrote to pharmacy professionals. “In these limited cases, deslorelin can only be legally compounded if it is done by or on the order of a licensed veterinarian within the practice of veterinary medicine, and if FDA-approved SucroMate Equine is used as the starting material.”
Thorn BioScience, a subsidiary of CreoSalus Inc., reported yesterday that it had already shipped its first SucroMate Equine vials for the upcoming mare breeding season.