Sugammadex Approval Status

Sugammadex is a novel selective relaxant binding agent (SRBA) specifically designed to reverse the effects of rocuronium bromide (Zemuron/Esmeron/Eslax) or vecuronium bromide, muscle relexants commonly used during surgical procedures.

FDA Approval Status for Sugammadex

DateArticle
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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