Gensia Sicor Announces FDA Approvals for Alprostadil
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 Sicor Pharmaceuticals, Inc., has received approval of an Abbreviated New Drug Application (ANDA) from the Food and Drug Administration (FDA) for Alprostadil Injection USP and a supplemental ANDA for Daunorubicin Hydrochloride for Injection USP, 50 mg. Alprostadil is indicated to temporarily maintain the patency of the ductus arteriosus in neonates who have congenital heart defects until corrective surgery can be performed and who depend upon the patent ductus for survival. Daunorubicin is used in the remission induction in acute myelogenous leukemia (AML) in adults and acute lymphocytic leukemia (ALL) in children and adults. According to IMS, a market research firm, U.S. sales of alprostadil and daunorubicin were approximately $14 million and $7 million in 1998, respectively. The branded product of alprostadil, 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 pharmaceutical company with proven expertise in the development, manufacturing and marketing of injectable pharmaceuticals and in the production of active pharmaceutical ingredients utilizing synthesis or fermentation. The company is focused on the worldwide oncology and injectable pharmaceutical markets. Gensia Sicor's commercial pharmaceutical businesses include Gensia Sicor Pharmaceuticals, Inc., a California-based manufacturer and marketer of multisource injectable 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 active pharmaceutical ingredients, and Lemery, S.A. de C.V. in Mexico City which manufactures injectable and oral finished multisource drug products. Gensia Sicor's company offices are located in Irvine, CA. 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 and those matters set forth in the risk factors section of Gensia 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 Gensia Sicor's new 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 Gensia Sicor, call 800-758-5804, extension 354050. Please retain these numbers for future reference. ots Original Text Service: Gensia Sicor Inc. Internet: http://www.newsaktuell.de Contact: Laurie W. Little of Gensia Sicor Inc., 949-455-4879; Carolyn Bass, Jim Byers, 415-296-7383, Patricia Walsh, or Mark Owen, 212-850-5600, all of Morgen-Walke Associates, 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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