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.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
investors, Wendy Carhart of Scios Inc.,
+1-408-616-8325; or Ed Bisno, +1-212-704-8212, or media, Michelle
Choi, +1-212-704-4580, both of Edelman Public Relations, for
Scios Inc.
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