October 20, 2005
FDA Approves TYLAN Soluble for the Control of American Foulbrood in Honey Bees
The U.S. Food and Drug Administration (FDA) has approved TYLAN (tylosin tartrate) Soluble for the control of American foulbrood (Paenibacillus larvae) in honey bees. This is the first approval for the use of TYLAN Soluble in a minor species (honey bees).
TYLAN Soluble, a product of Elanco Animal Health, a division of Eli Lilly and Company, Greenfield, Indiana, is already approved for therapeutic uses in chickens and swine and production uses in turkeys.
TYLAN Soluble is the second approved new animal drug for honey bees that controls American foulbrood (Paenibacillus larvae). FDA reviewed extensive data to ensure the product met all necessary effectiveness, animal health, human food safety, and environmental standards. The approval of this supplemental new animal drug application relied on publicly available safety and effectiveness data contained in Public Master File 5783, which were compiled under the oversight of the National Research Support Project-7 (NSRP-7), a national agricultural research program for obtaining clearances for use of new animal drugs in minor animal species and for special uses. Studies were conducted by USDAÂ’s Bee Research Laboratories. FDA has concluded that the honey derived from honey bees fed tylosin tartrate is safe when the animals are fed according to the approved labeling.
Additional information on this approval may be obtained by contacting Joan C. Gotthardt, D.V.M., Director, Division of Therapeutic Drugs for Food Animals, FDA, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV-130, Rockville, MD 20855, 301 827-7571; E-mail: firstname.lastname@example.org.