Oral Dosage Form New Animal Drugs; Tiamulin

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for use of an increased strength of tiamulin concentrate solution in the drinking water of swine for the treatment of certain bacterial respiratory and enteric diseases.

Agency Contact: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: cindy.burnsteel@fda.hhs.gov.