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Negocios · 15/7/19971 min de lectura

Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension

Traducción automática local · Idioma original de la fuente

Resumen

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.

Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →