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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

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

Summary:

Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

Summary:

McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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ASA FEATURED PRODUCT

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Self Education and Evaluation (SEE) Program

SKU: 30701-14CE

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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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