Bridion FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
FDA Approved: Yes (First approved December 15, 2015)
Brand name: Bridion
Generic name: sugammadex
Dosage form: Injection
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Bridion (sugammadex) is a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Development Timeline for Bridion
|Dec 16, 2015||Approval FDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular Blocking Drugs|
|Nov 6, 2015||Merck Statement on FDA Advisory Committee Meeting for Bridion (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium|
|Apr 28, 2015||Merck Receives Complete Response Letter for Sugammadex Sodium Injection|
|Mar 13, 2015||Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection|
|Sep 23, 2013||Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection|
|Jul 16, 2013||Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection|
|Jan 7, 2013||Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection|
|Aug 1, 2008||U.S. FDA Issues Action Letter for Sugammadex|
|Mar 12, 2008||FDA Advisory Committee Unanimously Recommends U.S. Approval ofSugammadex, the First and Only Selective Relaxant Binding Agent|
|Jan 3, 2008||Schering-Plough Announces New Drug Application for SugammadexAssigned Priority Review Status by U.S. FDA|
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