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Negócios · 16/05/20061 min de leitura
New Animal Drugs; Change of Sponsor; Fomepizole
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Resumo
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Orphan Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also being amended to reflect approval of a supplemental NADA to remove a vial of saline diluent from this product.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →