Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) issued to B. Braun Melsungen AG (B. Braun Melsungen) for Propofol-Lipuro 1% injectable emulsion (Propofol-Lipuro 1% emulsion). The EUA was issued on March 12, 2021. B. Braun Melsungen informed FDA that the inventory of the Propofol-Lipuro 1% emulsion within the United States has been depleted and that B. Braun Melsungen does not intend to offer this product in the United States anymore. Because B. Braun Melsungen has notified FDA that it does not intend to offer the Propofol-Lipuro 1% emulsion in the United States anymore and requested FDA revoke the EUA for the Propofol-Lipuro 1% emulsion, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.