SCHAUMBURG, Ill., Feb. 16 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Ceftriaxone for Injection, USP, with FDA's clearance of the issues surrounding the raw material supplier for this product. APP received approvals for five product codes for ceftriaxone, the generic equivalent of Roche Pharmaceuticals' Rocephin(R), including single dose and pharmacy bulk pack. According to IMS, ceftriaxone is the #1 third-generation cephalosporin in both dollar sales and units sold. Total annual sales in 2005 of ceftriaxone exceeded $570 million. APP will commence marketing immediately.
"Ceftriaxone is a crucial drug for our customers and one that physicians rely on to treat many serious infections," said Patrick Soon-Shiong, M.D., chairman and chief executive officer. "With the approval of ceftriaxone, APP retains its position with the largest portfolio of anti-infectives in the generic injectables industry and its leadership position in the cephalosporin market."
APP will supply ceftriaxone in 250mg, 500mg, 1g and 2g single-dose vials (SDV), as well as a 10g pharmacy bulk pack (PBP). The product is preservative-free and AP-rated, and each vial will include a bar code and latex-free vial stopper.
Ceftriaxone is a broad-spectrum anti-infective used to treat several types of bacterial infections, including: lower respiratory tract infections; acute bacterial otitis media; skin and skin structure infections; urinary tract infections; uncomplicated gonorrhea; pelvic inflammatory disease; bacterial septicemia; bone and joint infections; intra-abdominal infections; meningitis, and surgical prophylaxis. As with any antibiotic, ceftriaxone should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
About American Pharmaceutical Partners, Inc.
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.
Because these forward-looking statements, whether expressed or implied, involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, successfully commercializing ceftriaxone, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in our Form 10-K for the year ended December 31, 2004 and other documents filed by us with the Securities and Exchange Commission.
Rocephin(R) is a registered trademark of Roche Pharmaceuticals.
Contacts: American Pharmaceutical Partners, Inc.
Executive Vice President & CFO
Rob Whetstone/Robert Jaffe
American Pharmaceutical Partners, Inc.