APP Receives Expedited Approval for the First and Only Generic Cefotetan Disodium for Injection

  
    
  
  
    
      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      In 2006, AstraZeneca�s Cefotan was withdrawn 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.