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Biotech / Medical : IPIC
IPIC 0.00010000.0%Aug 15 3:35 PM EST

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To: muddphudd who wrote (1311)4/28/1999 10:08:00 AM
From: Trey Yon  Read Replies (1) of 1359
 
Scios pulls Natrcor NDA

MOUNTAIN VIEW, Calif., April 27 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO - news) announced today that the U.S. Food and Drug Administration did not approve the company's new drug application (NDA) for Natrecor® (nesiritide) in the treatment of acute episodes of congestive heart failure (CHF). Calling their action ''a particularly difficult decision,'' the agency determined there are uncertainties remaining about the effectiveness and safety of Natrecor at this time necessitating further study of the drug.

''We are disappointed in today's decision, nevertheless we will work closely with the FDA to define what additional clinical studies are required for the approval of Natrecor,'' said Richard B. Brewer, President and CEO of Scios Inc.

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