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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Approves First Insulin Product

FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3

The Food and Drug Administration’s Center for Veterinary Medicine has approved an insulin product for treatment of diabetes in dogs, making it the first diabetes drug approved for animals.

The drug’s sponsor, Intervet, Inc., Millsboro, Del., earlier this year received approval to begin marketing a drug for use in dogs to treat the clinical signs of diabetes, which include excessive thirst, urination and appetite, along with weight loss despite a good appetite.

Intervet’s product, called Vetsulin, is made from porcine insulin.

Previously, veterinarians would prescribe insulin approved for human use. Intervet’s product is made from porcine insulin and has the same amino acid sequence as canine insulin. By contrast, human insulin differs from the canine insulin by one amino acid, and bovine insulin differs from canine insulin by two amino acids.

The product will be available only through veterinarians, but owners will administer the drug to their dogs. The veterinarian can monitor the treatment to make all the necessary dosage adjustments until the optimum dose is found. The dogs will be treated either once or twice a day, based on their individual response to the drug.

The treatment is administered by injection along the dog’s back. Veterinarians will instruct owners on how to inject the dog, and the company will supply information sheets along with the drug to answer other questions.

Owners will need to be careful not to inject themselves with the product because it could cause hypoglycemia, a dangerously low level of sugar. However, the product has been used in other countries for many years with owners facing little difficulty.

According to FDA Acting Commissioner, Dr. Lester Crawford, the product “promises to improve the health and quality of life of dogs who suffer from this debilitating disease.” As many as one out of 200 dogs suffers from diabetes. Female dogs are twice as likely to develop the disease, and it usually starts when a dog is seven to nine years old.

The product should be generally available later this year, the company said.