Bridion
Generic name: sugammadex
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Merck Receives Complete Response Letter for Sugammadex Sodium Injection
KENILWORTH, N.J - Tuesday, April 28, 2015 -- Merck & Co., Inc. today announced that the company received a Complete Response Letter (CRL) from the FDA for sugammadex injection, an investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Merck is evaluating the information provided in the CRL. Sugammadex injection is marketed as Bridion in more than 60 countries.
Source: Merck & Co., Inc.
Posted: April 2015
Related articles
- FDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular Blocking Drugs - December 16, 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 - November 6, 2015
- Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection - March 13, 2015
- Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection - September 23, 2013
- Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection - July 16, 2013
- Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection - January 7, 2013
- U.S. FDA Issues Action Letter for Sugammadex - August 1, 2008
- FDA Advisory Committee Unanimously Recommends U.S. Approval ofSugammadex, the First and Only Selective Relaxant Binding Agent - March 12, 2008
- Schering-Plough Announces New Drug Application for SugammadexAssigned Priority Review Status by U.S. FDA - January 3, 2008
Bridion (sugammadex) FDA Approval History
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