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Heart Failure

Pharma company submits interim report to U.S. FDA on Natrecor PROACTION Trial for heart failure

Published in Cardiovascular Week, January 30th, 2006

Scios Inc. announced it is submitting an interim report to the U.S. Food & Drug Administration, and other relevant international regulatory authorities, on an ongoing expanded analysis of a 3-year-old exploratory health outcomes study (the PROACTION trial) comparing treatment with Natrecor (nesiritide) to placebo for heart failure.

The interim report contains two additional deaths that had occurred within 30 days after treatment with Natrecor but had not been initially reported to the company.

The two new cases were not included in a report on the PROACTION study that was published in the 2005 October issue of the Journal of Emergency...

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