Scios expects Natrecor approval in the first week of August and plans to launch the product in September. FDA's San Francisco District Office told the company it will recommend approval of nesiritide following its completion of a pre-approval manufacturing inspection July 18. Full approval of Natrecor for the treatment of acutely decompensated congestive heart failure awaits final labeling discussions that are coming to a close at FDA, Scios said. Natrecor has been "approvable" since July 10 (1"The Pink Sheet" July 16, p. 15)
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Scios will initiate a congestive heart failure patient registry in conjunction with the launch of Natrecor (nesiritide) for treatment of acute decompensated CHF, CEO Richard Brewer said July 10.
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