Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced the approval from the U.S. Food and Drug Administration (FDA) to market Cefotetan Disodium for Injection, the generic equivalent of AstraZeneca�s Cefotan�. Cefotetan has the longest half-life of any first or second generation cephalosporin and offers surgeons a convenient single-dose option for surgical prophylaxis and secondary infections. APP, now as the only supplier of this drug, expects to launch this important anti-infective back into the market this month. Based on previous IMS data, Cefotetan has market potential in excess of $40 million. �As a surgeon, I am very excited to have Cefotetan back in our arsenal. Its anaerobic coverage, single-dose administration and long half-life make it a unique and valuable surgical prophylactic,� said Marc Singer, M.D., assistant professor of surgery at the University of Illinois at Chicago. �Access to this drug will help surgeons prevent post-operative infections, which, if not successfully prevented, can have serious consequences resulting in illness or even death.� �In addition, compliance with peri-operative antibiotic administration has become a strictly monitored quality assurance measure. With Cefotetan, we may not need to re-dose in the operating room which will ultimately help to improve both patient safety and compliance,� continued Singer. Evidence-based treatment guidelines reported by the American Society of Health-System Pharmacists (ASHP) indicate that Cefotetan is the preferred agent for abdominal or vaginal hysterectomy and cesarean section, and is recommended for colorectal surgery. In 2006, AstraZeneca�s Cefotan was withdrawn from the marketplace due to issues with sourcing of raw material. �We have secured a new, alternate raw material supplier versus the company previously utilized by the innovator and are confident in their experience in cephalosporin raw material manufacturing and ability to provide consistent supply," said Thomas Silberg, president of Abraxis Pharmaceutical Products. "APP already markets an anti-infective portfolio that is unmatched. The addition of Cefotetan to this product line has the potential to bolster APP's leadership position in this category.� As a second-generation cephalosporin, Cefotetan is administered prior to surgery to help prevent surgical prophylaxis and secondary infection following certain abdominal and gynecological procedures such as colorectal surgery, vaginal or abdominal hysterectomies and cesarean sections. Cefotetan is also indicated for treating and preventing infections elsewhere in the body that are proven or strongly suspected to be caused by susceptible bacteria, including urinary tract infections, lower respiratory tract infections, skin and skin structure infections, gynecologic infections, intra-abdominal infections and bone and joint infections. Cefotetan will initially be available in 1g and 2g vials. The product is AP-rated and preservative free, and each vial will include a bar code and latex-free vial stopper. Cefotetan for Injection is indicated for preoperative administration of surgical procedures that are classified as clean contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery). The adverse event profile of Cefotetan for Injection is similar to that of other cephalosporin antibiotics. The following adverse events were reported in clinical studies: gastrointestinal, 1.5%; hematologic, 1.4%; hepatic, 1.2%; hypersensitivity, 1.2%; local, 1.0%. About Abraxis Pharmaceutical Partners (APP) APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on hospital-based anti-infective, critical care, oncology and anesthetic/analgesic markets. With products totaling over 400 dosage forms and a market-leading pipeline, APP offers patients and healthcare providers one of the broadest portfolios of injectable products in the United States. On July 2, 2007, parent company Abraxis BioScience (Nasdaq:ABBI) announced that APP and its proprietary business will become separate independent public companies, subject to the satisfaction of various closing conditions, to enable the two business units to concentrate on their core competencies and compete more effectively in their respective marketplaces. APP is headquartered in Schaumburg, IL. For more information, visit www.appdrugs.com. About Abraxis BioScience, Inc. Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab� platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE�, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
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