SCHAUMBURG, Ill., Nov. 30 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the combination drug Ampicillin and Sulbactam for Injection, USP, the generic equivalent of Pfizer Inc.'s Unasyn(R). Annual sales in 2004 of this product exceeded $116 million, of which $83 million was sold in vials, according to IMS. APP expects to commence marketing Ampicillin and Sulbactam immediately.
“The addition of Ampicillin and Sulbactam brings to 17 the number of generic anti-infective products in our portfolio and bolsters our industry leading position for these types of injectable products,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer. “Our ability to provide customers with a wide array of anti-infectives enabled us to have GPO contracts in place at launch.”
Ampicillin and Sulbactam will be available from APP in 1.5g and 3g single dose vials (SDV). The product is preservative-free and AP rated and each vial will include a bar code and latex-free vial stopper. The approval is the fifth product approval APP has received this year.
Ampicillin and Sulbactam is an injectable antibacterial combination consisting of the seminsynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. Administered intravenously or intramuscular, Ampicillin and Sulbactam is indicated for the treatment of several skin and skin structure, intra-abdominal and gynecological infections due to susceptible strains of 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(TM), 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 ampicillin and sulbactam, 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.
Unasyn(R) is a registered trademark of Pfizer, Inc. Contacts: American Pharmaceutical Partners, Inc. Nicole Williams Executive Vice President & CFO (847) 969-2700 PondelWilkinson Robert Jaffe/Rob Whetstone (310) 279-5969
American Pharmaceutical Partners, Inc.
CONTACT: Nicole Williams, Executive Vice President & CFO of AmericanPharmaceutical Partners, Inc., +1-847-969-2700; or Robert Jaffe or RobWhetstone, both of PondelWilkinson, +1-310-279-5969, for AmericanPharmaceutical Partners, Inc.
