Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension

摘要

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Lambert-Kay, Division of Carter-Wallace, Inc. The supplemental ANADA provides for oral use 4.54 milligrams per milliliter (mg/mL) pyrantel pamoate suspension in addition to the 2.27 mg/mL product for removal of large roundworms and hookworms in puppies and dogs and to prevent reinfections of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.