Zeneca, Inc.; Withdrawal of Approval of Portion of a New Drug Application Providing for a Formulation of Diprivan Injectable Emulsion Not Containing Disodium Edetate

摘要

The Food and Drug Administration (FDA) is withdrawing approval of those portions of a new drug application (NDA) held by Zeneca, Inc., (Zeneca) for Diprivan (propofol) Injectable Emulsion that provide for a formulation not containing the antimicrobial additive disodium edetate.