SICOR Announces Resolution of Warning Letter From the
26.08.1999, 14:33
FDA and ANDA Approval For Vecuronium Bromide for Injection
Irvine, Calif. (PROTEXT) - SICOR Inc. (Nasdaq: SCRI) today
announced that its wholly owned subsidiary, Gensia Sicor
Pharmaceuticals, Inc., has resolved all outstanding concerns
raised by the Food and Drug Administration (FDA) in a Warning
Letter received by the Company on July 21,1999. The FDA was
satisfied that the response to the Warning Letter and that the
corrective actions that Gensia Sicor Pharmaceuticals has adopted
and implemented have sufficiently addressed their concerns in the
areas of cleaning validation of certain compounding tanks and
information system data storage.
SICOR also announced today that its wholly owned subsidiary,
Gensia Sicor Pharmaceuticals, Inc., has received approval from
the FDA of an Abbreviated New Drug Application (ANDA) for
Vecuronium Bromide for Injection, a drug used as an adjunct to
general anesthesia, to facilitate endotracheal intubation and to
provide skeletal muscle relaxation during surgery or mechanical
ventilation.
According to IMS, a market research firm, U.S. sales of
vecuronium were approximately $43 million in 1998. The branded
product, Norcuron(R) for Injection, is marketed by Organon, Inc.
SICOR Inc. is a vertically integrated specialty pharmaceutical
company with proven expertise in the development, manufacturing
and marketing of multi-source injectable pharmaceuticals. With a
strategy of combining both the production of active
pharmaceutical ingredients utilizing chemical synthesis or
fermentation and state of the art manufacturing facilities,
SICOR's primary focus is on the worldwide injectable
pharmaceutical market, which currently includes oncology,
anesthesiology, cardiology and other therapeutic areas. SICOR
operates several manufacturing facilities in Europe, Mexico and
the U.S.A., while maintaining the corporate headquarters in
Irvine, California.
This press release contains forward looking statements that
are subject to risks and uncertainties that could cause actual
results to differ materially from those set forth in the forward
looking statements including whether the quality initiatives will
completely resolve all FDA concerns, whether the FDA is
completely satisfied, and those matters set forth in the risk
factors section of SICOR's filings on Forms 10-K and 10-Q with
the Securities and Exchange commission. These forward looking
statements represent the Company's judgment as of the date of
this press release. The Company disclaims any intent or
obligation to update these forward looking statements.
For more information on the Company visit SICOR's web site at
www.gensiasicor.com. News releases are also available at no
charge through PR Newswire's News On-Call fax service. For a menu
of available news releases or to retrieve a specific release made
by SICOR, call 800-758-5804, extension 354050. Please retain
these numbers for future reference. ots Original Text Service:
SICOR Inc. Internet: http://www.newsaktuell.de Contact: Laurie
W. Little of SICOR Inc., (USA) 949-455-4879; or Carolyn Bass or
Jim Byers, (USA) 415-296-7383, or Patricia Walsh or Eric
Gonzales, (USA) 212-850-5600, all of Morgen-Walke Associates,
Inc., for SICOR Inc. Company News On-Call:
http://www.prnewswire.com/comp/354050.html or Fax, (USA) 800-
758-5804, ext. 354050 Web site: http://www.gensiasicor.com
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