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) todayannounced that its wholly owned subsidiary, Gensia SicorPharmaceuticals, Inc., has resolved all outstanding concernsraised by the Food and Drug Administration (FDA) in a WarningLetter received by the Company on July 21,1999. The FDA wassatisfied that the response to the Warning Letter and that thecorrective actions that Gensia Sicor Pharmaceuticals has adoptedand implemented have sufficiently addressed their concerns in theareas of cleaning validation of certain compounding tanks andinformation system data storage. SICOR also announced today that its wholly owned subsidiary,Gensia Sicor Pharmaceuticals, Inc., has received approval fromthe FDA of an Abbreviated New Drug Application (ANDA) forVecuronium Bromide for Injection, a drug used as an adjunct togeneral anesthesia, to facilitate endotracheal intubation and toprovide skeletal muscle relaxation during surgery or mechanicalventilation. According to IMS, a market research firm, U.S. sales ofvecuronium were approximately $43 million in 1998. The brandedproduct, Norcuron(R) for Injection, is marketed by Organon, Inc. SICOR Inc. is a vertically integrated specialty pharmaceuticalcompany with proven expertise in the development, manufacturingand marketing of multi-source injectable pharmaceuticals. With astrategy of combining both the production of activepharmaceutical ingredients utilizing chemical synthesis orfermentation and state of the art manufacturing facilities,SICOR's primary focus is on the worldwide injectablepharmaceutical market, which currently includes oncology,anesthesiology, cardiology and other therapeutic areas. SICORoperates several manufacturing facilities in Europe, Mexico andthe U.S.A., while maintaining the corporate headquarters inIrvine, California. This press release contains forward looking statements thatare subject to risks and uncertainties that could cause actualresults to differ materially from those set forth in the forwardlooking statements including whether the quality initiatives willcompletely resolve all FDA concerns, whether the FDA iscompletely satisfied, and those matters set forth in the riskfactors section of SICOR's filings on Forms 10-K and 10-Q withthe Securities and Exchange commission. These forward lookingstatements represent the Company's judgment as of the date ofthis press release. The Company disclaims any intent orobligation to update these forward looking statements. For more information on the Company visit SICOR's web site atwww.gensiasicor.com. News releases are also available at nocharge through PR Newswire's News On-Call fax service. For a menuof available news releases or to retrieve a specific release madeby SICOR, call 800-758-5804, extension 354050. Please retainthese numbers for future reference. ots Original Text Service:SICOR Inc. Internet: http://www.newsaktuell.de Contact: LaurieW. Little of SICOR Inc., (USA) 949-455-4879; or Carolyn Bass orJim Byers, (USA) 415-296-7383, or Patricia Walsh or EricGonzales, (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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