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 Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT

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