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New Drug Application for Generic Equivalent of Unasyn Approved by FDA

SCHAUMBURG, Ill., Nov. 30 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (NASDAQ:APPX) , 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.

Source: American Pharmaceutical Partners

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