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MEETINGS / EVENTS

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May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

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FDA MEDWATCH ALERTS

April 18, 2014

Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Summary:

Propofol Injectable Emulsion USP by Hospira Recall Visible Particulates

April 18, 2014

FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

Summary:

FDA MedWatch Class I Recall 4 18 14

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

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ASA FEATURED PRODUCT

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Anesthesiology Continuing Education (ACE) Program

SKU: 30702-14CE

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Single Copies, Member Price: $360

FDA Rejects Sugammadex Application

Monday, September 23, 2013

On September 23, Merck Inc. announced it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) informing the company that its resubmitted New Drug Application for sugammadex had been rejected.  According to Merck, the FDA raised issues with "operational aspects of a hypersensitivity study" that the FDA had requested in 2008. 

ASA had previously expressed strong support for the approval of sugammadex in a formal comment letter to the FDA's Anesthetic and Analgesic Drug Products Advisory Committee. The proposed indications for use of sugammadex are the routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium, and the immediate reversal of NMB at 3 minutes after administration of rocuronium.

Review ASA's previous support.

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