Gensia Sicor Announces FDA Approvals for Alprostadil

5.05.1999, 14:38

Injection USP and Daunorubicin Hydrochloride for Injection USP,50 Mg IRVINE, Calif. (PROTEXT) - Gensia Sicor Inc. (Nasdaq: GNSA)today announced that its wholly owned subsidiary, Gensia SicorPharmaceuticals, Inc., has received approval of an AbbreviatedNew Drug Application (ANDA) from the Food and Drug Administration(FDA) for Alprostadil Injection USP and a supplemental ANDA forDaunorubicin Hydrochloride for Injection USP, 50 mg. Alprostadilis indicated to temporarily maintain the patency of the ductusarteriosus in neonates who have congenital heart defects untilcorrective surgery can be performed and who depend upon thepatent ductus for survival. Daunorubicin is used in the remissioninduction in acute myelogenous leukemia (AML) in adults and acutelymphocytic leukemia (ALL) in children and adults. According to IMS, a market research firm, U.S. sales ofalprostadil and daunorubicin were approximately $14 million and$7 million in 1998, respectively. The branded product ofalprostadil, Prostin VR Pediatric(R), is marketed by Pharmacia &Upjohn, Inc. The branded product of daunorubicin, Cerubidine(R),is marketed by Bedford Laboratories in a 20 mg vial. Gensia Sicor Inc. is a vertically integrated pharmaceuticalcompany with proven expertise in the development, manufacturingand marketing of injectable pharmaceuticals and in the productionof active pharmaceutical ingredients utilizing synthesis orfermentation. The company is focused on the worldwide oncologyand injectable pharmaceutical markets. Gensia Sicor's commercialpharmaceutical businesses include Gensia Sicor Pharmaceuticals,Inc., a California-based manufacturer and marketer of multisourceinjectable drugs, SICOR-Societa Italiana Corticosteroidi S.p.A.and Diaspa S.p.A., both of Milan Italy, and Sicor de Mexico, S.A.de C.V. in Toluca, Mexico all which produce of activepharmaceutical ingredients, and Lemery, S.A. de C.V. in MexicoCity which manufactures injectable and oral finished multisourcedrug products. Gensia Sicor's company offices are located inIrvine, CA. 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 and those matters set forth in the riskfactors section of Gensia Sicor's filings on Forms 10-K and 10-Qwith the Securities and Exchange Commission. These forwardlooking statements represent the Company's judgment as of thedate of this press release. The Company disclaims any intent orobligation to update these forward looking statements. For more information on the Company, visit Gensia Sicor's newweb site at www.gensiasicor.com. News releases are also availableat no charge through PR Newswire's News On-Call fax service. Fora menu of available news releases or to retrieve a specificrelease made by Gensia Sicor, call 800-758-5804, extension354050. Please retain these numbers for future reference. otsOriginal Text Service: Gensia Sicor Inc. Internet:http://www.newsaktuell.de Contact: Laurie W. Little of GensiaSicor Inc., 949-455-4879; Carolyn Bass, Jim Byers, 415-296-7383,Patricia Walsh, or Mark Owen, 212-850-5600, all of Morgen-WalkeAssociates, Inc., for Gensia Sicor Inc. Company News On-Call:http://www.prnewswire.com/comp/354050.html or fax, 800-758-5804,ext. 354050 Web site: http://www.gensiasicor.com

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