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Bridion FDA Approval History

FDA Approved: Yes (First approved December 15, 2015)
Brand name: Bridion
Generic name: sugammadex
Dosage form: Injection
Company: Merck
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

Bridion (sugammadex) is a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

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Development timeline for Bridion

DateArticle
Dec 16, 2015Approval FDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular Blocking Drugs
Nov  6, 2015Merck 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, 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 ofSugammadex, the First and Only Selective Relaxant Binding Agent
Jan  3, 2008Schering-Plough Announces New Drug Application for SugammadexAssigned Priority Review Status by U.S. FDA

See also

Bridion (sugammadex) Consumer information

Further information

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