FDA Accepts Merck New Drug Application for Sugammadex Sodium Injection

Merck’s new drug application resubmission for sugammadex sodium injection has been accepted for review by the FDA.

Advertisement

Neuromuscular blockade, which is used by anesthesiologists to relax muscles during surgery, is revered by the sugammadex sodium injection. Upon approval, this substance would be one of the first medicines of its kind to be used in the U.S. surgical setting.

The FDA previously rejected the NDA in 2008 and requested more data on allergic reactions and bleeding events. The application has now been deemed complete for review.

More Articles on Anesthesia:

Novitas Expected to Revise Limits to Anesthesia Coverage
6 ASC Characteristics That Matter to Anesthesiologists
Children’s National Medical Center Names Joint Chief Medical Officers

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Advertisement

Next Up in Anesthesia

Advertisement

Comments are closed.