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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 21, 2014

Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates

Summary:

Lidocaine HCI Injection USP by Hospira Recall Visible Particulates

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

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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

ASA Supports New Drug Application for Sugammadex

Tuesday, July 02, 2013

In a formal comment letter to the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee, ASA expressed strong support for the approval of sugammadex. 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. The FDA Advisory Committee will meet on July 18 to discuss this New Drug Application (NDA), which was submitted by Organon USA Inc.

In support of the application, ASA stated that "sugammadex is a novel, unique drug that provides anesthesiologists [with] better capabilities to reverse moderate and deep NMB. It is not just a 'better' reversal agent, but one that provides a new paradigm for anesthesia care. Sugammadex will significantly enhance the ability of anesthesiologists to more safely care for patients and reduce the incidence of critical respiratory adverse events in the PACU, especially for patients most at risk."

ASA will continue to closely monitor FDA’s action on the sugammadex application.

Review ASA's formal support to the FDA for sugammadex. 
Learn more about the FDA’s New Drug Application process.

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