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Biotech / Medical : SCIO Scios Inc. -- Ignore unavailable to you. Want to Upgrade?


To: Ian@SI who wrote (1390)7/19/2001 9:22:27 AM
From: Linda Pearson  Read Replies (1) | Respond to of 1477
 
Scios Completes Pre-Approval Inspection for Natrecor


SUNNYVALE, Calif., July 19 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO) announced today that it has been informed by the San Francisco District Office of the U.S. Food and Drug Administration (FDA) that the Natrecor(R) (nesiritide) pre-approval inspection has been completed. The District Office informed Scios that they will recommend approval of the Natrecor New Drug Application (NDA) to the Center for Drug Evaluation and Research (CDER). CDER is the responsible Center within the FDA for evaluating the Natrecor NDA. Scios has developed Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure.

Scios also announced that the remaining item to be completed before CDER issues the final action letter on the Natrecor NDA is the finalization of the Natrecor labeling. Discussions with the agency on the final labeling are ongoing.

Scios Inc.

Scios is a biopharmaceutical company developing novel treatments for cardiovascular and inflammatory disease. The Company's disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds for large markets with unmet medical needs.

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. These include uncertainties associated with the timing of the final approval of Natrecor, as well as other risks detailed from time to time in the reports filed by Scios with the SEC, including the company's annual report on form 10-K for the year ended December 31, 2000 and form 10-Q for the quarter ended March 31, 2001.

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SOURCE Scios Inc.

CO: Scios Inc.

ST: California

IN: MTC BIO

SU:

07/19/2001 08:00 EDT prnewswire.com