BridionTreatment for Reversal of Nondepolarizing Muscle Relaxants
Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed today that the U.S. Food and Drug Administration (FDA) has cancelled Thursday’s discussion of sugammadex at the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Sugammadex sodium injection is Merck’s investigational medicine for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium.
The FDA advised Merck that the agency needs additional time to assess the results of the FDA’s recently completed inspection of a clinical trial site. The site was one of four sites that conducted the hypersensitivity study previously requested by the agency. Merck is engaged in discussions with the FDA to identify the steps necessary to enable the agency to complete its review.
“Merck believes that sugammadex is an important treatment option for an unmet medical need in anesthesia, and we will work with the FDA on the next steps to bring this innovation forward to patients in the United States,” said David Michelson, M.D., head of global clinical development for neuroscience, Merck Research Laboratories.
Sugammadex is marketed in 40 countries other than the U.S., and more than five million vials of sugammadex have been sold as of March 2013.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.
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Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site.
Posted: July 2013
- 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 Receives Complete Response Letter for Sugammadex Sodium Injection - April 28, 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 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