SCHAUMBURG, Ill., Dec. 14 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Azithromycin for Injection, the generic equivalent of Pfizer Inc.'s Zithromax®. Sales of this product exceeded $69 million in 2004 and were more than $74 million through the first nine months of 2005, according to IMS. APP expects to commence marketing Azithromycin in the 2006 first quarter, with GPO contracts in place.
“The addition of Azithromycin expands our anti-infective portfolio to 18 products and extends to 11 the number of different classes of anti-infectives APP offers,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer. “Azithromycin is the sixth multi-source product approval APP has received this year.”
Azithromycin will be available from APP in 500 mg vials. The product is preservative-free and AP rated and each vial will include a bar code and latex-free vial stopper.
Azithromycin for Injection is indicated for the treatment of community-acquired pneumonia and pelvic inflammatory disease, when caused by susceptible microorganisms.
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®, recently launched for the treatment of metastatic breast cancer. 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 azithromycin, 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.
Zithromax is a registered trademark of Pfizer, Inc.
Source: American Pharmaceutical Partners, Inc.
