Karen Eggert (301) 734-7280
Jerry Redding (202) 720-4623
USDA ISSUES CONDITIONAL LICENSE FOR CANINE MELANOMA VACCINE
WASHINGTON, March 26, 2007--The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service today announced that it has issued a conditional license to Merial, Inc., of Athens, Ga., for a melanoma vaccine to aid in the treatment of oral cancer in dogs.
APHIS issues conditional licenses for veterinary biologics to respond to emergency situations, limited markets, local situations or special circumstances. In this case, the vaccine has been shown to aid in cancer treatment for dogs and has demonstrated a reasonable expectation of efficacy to increase the survival time of dogs with oral melanoma.
Canine malignant melanoma is a spontaneous, aggressive, and metastatic eoplasm. The diagnosis of canine malignant melanoma represents approximately 4 percent of all canine tumors, and is the most common oral tumor in dogs. This vaccine is approved for treatment of dogs with stage II or stage III oral melanoma in cases in which the disease has been contained.
Conditional licenses are generally issued with restrictions and for a limited period of time. This product has been issued a conditional license for one year. At the end of the conditional license period, data obtained in support of the product’s performance will be evaluated to determine if the conditional license should be renewed or if a regular product license may be issued. Only veterinarians in those states where use of the product has been approved by the appropriate state regulatory authorities can use this product.
#
Note to Reporters: USDA news releases, program announcements and media advisories are available on the Internet. Go to the APHIS news release page at http://www.aphis.usda.gov/newsroom. Also, anyone with an e-mail address can sign up to receive APHIS press releases automatically. Send an e-mail message to lyris@mdrdlyriss10.aphis.usda.gov and leave the subject blank. In the message, type
subscribe press_releases.