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Sugammadex Approval Status

Sugammadex is an investigational novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

In April 2015, Merck & Co., Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for sugammadex had not been approved.

FDA Approval Status for Sugammadex

DateArticle
Apr 28, 2015Merck Receives Complete Response Letter for Sugammadex Sodium Injection
Mar 13, 2015Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection
Sep 23, 2013Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection
Jul 16, 2013Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection
Jan  7, 2013Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection
Aug  1, 2008U.S. FDA Issues Action Letter for Sugammadex
Mar 12, 2008FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Jan  3, 2008Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA

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