American Pharmaceutical Partners Reports on Status of Ceftriaxone Product Approval
Posted on: Thursday, 28 July 2005, 18:01 CDT
SCHAUMBURG, Ill., July 28 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today said that based on updated information received this week from its raw material supplier regarding the results of a Food and Drug Administration inspection of this supplier, the company does not anticipate receiving approval for its Abbreviated New Drug Application (ANDA) for Ceftriaxone for Injection, USP, in the near term. APP said that this situation does not affect any currently marketed products. The company also said that its previous guidance of 8%-10% annual growth in its core generic injectable business remains unchanged.
About American Pharmaceutical Partners
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(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at http://www.appdrugs.com/ and http://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, the timing of and costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, the fact that actual results achieved in further Phase II and III trials for ABRAXANE may or may not be consistent with results achieved to date, 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.
Contacts: American Pharmaceutical Partners, Inc. Nicole Williams Executive Vice President & CFO (847) 969-2700 Rob Whetstone/Robert Jaffe PondelWilkinson Inc. (310) 279-5963
American Pharmaceutical Partners, Inc.
CONTACT: Nicole Williams, Executive Vice President & CFO of AmericanPharmaceutical Partners, Inc., +1-847-969-2700; or Rob Whetstone or RobertJaffe of PondelWilkinson Inc., +1-310-279-5963, for American PharmaceuticalPartners, Inc.
Web site: http://www.appdrugs.com/http://www.abraxisoncology.com/
Source: PRNewswire-FirstCall
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