J&J Reaches Deal With FDA to Revive Sedasys Device Application
Johnson & Johnson (JNJ), the world’s second-biggest seller of health products, reached an agreement with U.S. regulators to reopen its application for the Sedasys sedation system for endoscopy patients.
The company said it withdrew an appeal of the Food and Drug Administration’s April 2010 denial of the Sedasys application because of the agreement. An FDA advisory panel was scheduled to meet Dec. 14 on the appeal.
Sedasys is a computer-assisted system that administers propofol for patients being screened for colorectal cancer or undergoing upper gastrointestinal procedures. A trial showed patients who used Sedasys had a lower risk of over-sedation than those given benzodiazepine and opioids, New Brunswick, New Jersey-based J&J said.
“We’ve worked cooperatively with the FDA in recent months to address the agency’s concerns and we’re optimistic that we now have a path forward that will allow us to bring this important innovation to market,” Karen Licitra, company group chairwoman and worldwide franchise chairwoman for J&J subsidiary Ethicon Endo-Surgery Inc., said today in a statement.
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