The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for oral use of moxidectin solution in sheep for the treatment and control of a variety of internal parasites.
Under the Federal Food, Drug and Cosmetic Act, this approval qualifies for seven years of exclusive marketing rights beginning Nov. 30, 2005, because this drug has been declared a designated new animal drug by FDA. The new drug was also approved for use as of this date.
One limitation on the use of this drug is that sheep must not be slaughtered for human consumption within seven days of treatment.
This is good news, says Jim Logan, DVM, chairman of the American Sheep Industry Association?s (ASI) Health Committee. "ASI has listed new anthelmintics for sheep as one of the top priorities for our industry when meeting with FDA/Center for Veterinary Medicine."
Logan also cautions that inappropriate and overuse of anthelmintics has been demonstrated to render otherwise good de-wormers ineffective; he urges producers to "make sure they follow the label and confirm you have a problem before you treat."