Notice of Approval of Abbreviated New Animal Drug Application; Dexamethasone Sodium Phosphate Injection

摘要

The Food and Drug Administration's Center for Veterinary Medicine (CVM) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the veterinary prescription use of dexamethasone sodium phosphate injectable solution as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. The applicable sections of the regulations did not require amendment.