14.05.1999, 16:50
Gensia Sicor Announces ANDA Approval for Haloperidol DecanoateInjection Irvine, Calif. (ots-PRNewswire) - Gensia Sicor Inc. (Nasdaq:GNSA)today announced that its wholly owned subsidiary, Gensia SicorPharmaceuticals, Inc., has received approval of an AbbreviatedNewDrug Application (ANDA) from the Food and Drug Administration(FDA)for Haloperidol Decanoate Injection, a drug used in themanagement ofmanifestations of psychotic disorders. According to IMS, a market research firm, U.S. sales ofhaloperidol were approximately $57 million in 1998. The brandedproduct, Haldol(R) Decanoate Injection, is marketed by Ortho-McNeilPharmaceutical. Gensia Sicor Inc. is a vertically integrated pharmaceuticalcompany with proven expertise in the development, manufacturingandmarketing of injectable pharmaceuticals and in the production ofspecialty bulk drug substances utilizing synthesis orfermentation.The company is focused on the worldwide oncology and injectablepharmaceutical markets. Gensia Sicor's commercial pharmaceuticalbusinesses include Gensia Sicor Pharmaceuticals, Inc., aCalifornia-based manufacturer and marketer of multisourceinjectabledrugs, SICOR-Societa Italiana Corticosteroidi S.p.A. and DiaspaS.p.A., both of Milan Italy, and Sicor de Mexico, S.A. de C.V. inToluca, Mexico all which produce specialty bulk drug substances,andLemery, S.A. de C.V. in Mexico City which manufactures injectableandoral finished multisource drug products. Gensia Sicor's companyoffices are located in Irvine, CA. This press release contains forward looking statements thataresubject to risks and uncertainties that could cause actualresults todiffer materially from those set forth in the forward lookingstatements and those matters set forth in the risk factorssection ofGensia Sicor's filings on Forms 10-K and 10-Q with the SecuritiesandExchange Commission. These forward looking statements representtheCompany's judgment as of the date of this press release. TheCompanydisclaims any intent or obligation to update these forwardlookingstatements. For more information on the Company, visit Gensia Sicor's newwebsite at http://www.gensiasicor.com. News releases are alsoavailableat no charge through PR Newswire's News On-Call fax service. Foramenu of available news releases or to retrieve a specific releasemade by Gensia Sicor, call 800-758-5804, extension 354050. Pleaseretain these numbers for future reference.ots Original Text Service: Gensia Sicor Inc.Internet: http://www.newsaktuell.deContact: Laurie W. Little of Gensia Sicor Inc., (USA) 949-455-4879;or Carolyn Bass, Jim Byers, (USA) 415-296-7383, or PatriciaWalsh,Mark Owen, (USA) 212-850-5600, all of Morgen-Walke Associates,Inc.Company News On-Call: http://www.prnewswire.com/comp/354050.htmlorfax, (USA) 800-758-5804, ext. 354050Web site: http://www.gensiasicor.come-mail:
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