Bridion
Generic name: sugammadex
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection
KENILWORTH, N.J., March 13, 2015 --(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review.
About Merck
Today’s Merck is a global health care 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 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 health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, Merck’s ability to complete the offering and Merck’s expectations for the use of proceeds from the offering. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and timing of the offering.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 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 (www.sec.gov).
Source: Merck & Co., Inc.
Posted: March 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 Receives Complete Response Letter for Sugammadex Sodium Injection - April 28, 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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