American Pharmaceutical gets FDA OK of Ampicillin, Sulbactam for Injection, generic of Pfizer's Unasyn

By E. Janene Geiss

Philadelphia, Nov. 30 - American Pharmaceutical Partners, Inc. said Wednesday that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the combination drug Ampicillin and Sulbactam for Injection, USP, the generic equivalent of Pfizer Inc.'s Unasyn.

Annual sales in 2004 of this product exceeded $116 million, of which $83 million was sold in vials, according to a company news release.

American Pharmaceutical said it expects to begin marketing Ampicillin and Sulbactam immediately.

The addition of Ampicillin and Sulbactam brings to 17 the number of generic anti-infective products in the company's portfolio and bolsters its position for these types of injectable products, officials said.

"Our ability to provide customers with a wide array of anti-infectives enabled us to have GPO contracts in place at launch," said chairman and chief executive officer Patrick Soon-Shiong in the release.

Ampicillin and Sulbactam is an injectable antibacterial combination that is administered intravenously or intramuscular. It is indicated for the treatment of several skin and skin structure, intra-abdominal and gynecological infections due to susceptible strains of microorganisms.

Ampicillin and Sulbactam will be available in 1.5g and 3g single dose vials. 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 the company has received this year, officials said.

American Pharmaceutical is a Schaumburg, Ill., specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.

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