Business · 10/12/1998Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval for Diprivan Injectable Emulsion Without Disodium Edetate
Summary
The US Food and Drug Administration (FDA) has withdrawn its approval for a portion of Zeneca's (now AstraZeneca) new drug application for Diprivan Injectable Emulsion, a formulation of propofol, due to the absence of the antimicrobial additive disodium edetate.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →