Reuters: Regulatory News: FDA approves J&J sedation drug device

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FDA approves J&J sedation drug device May 4th 2013, 01:05 Fri May 3, 2013 9:05pm EDT May 3 (Reuters) - U.S. regulators have approved Johnson & Johnson's Sedasys system to sedate patients during colonoscopies without the need for a physician to monitor delivery of the injectable sedating agent, the company said on Friday. The device injects the patients who have different types of colonoscopy procedures with propofol, a minimal-to-moderate sedation agent widely used in colonoscopy procedures. The system reduces the risks of oversedation when compared to other traditional methods, Johnson & Johnson said in a release, with 99 percent of patients recovering from the effects within 10 minutes after administration of the drug. J&J said the system is expected to be introduced on a limited basis beginning in 2014. The company estimates that 15 million patients in the United States are candidates for these procedures.

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