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American Pharmaceutical wins approval for generic anti-infective

American Pharmaceutical Partners has received approval from the FDA to market azithromycin for injection, its generic version of Pfizer's anti-infective drug, Zithromax.

The product is indicated for the treatment of community-acquired pneumonia and pelvic inflammatory disease, when caused by susceptible microorganisms.

Sales of this product exceeded $69 million in 2004 and were more than $74 million through the first nine months of 2005. American Pharmaceutical expects to commence marketing of its generic version of the product in the 2006 first quarter.

“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 Dr Patrick Soon-Shiong, chairman and CEO.

American Pharmaceutical Partners develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.