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APP OK'd for generic Zithromax

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Published: Dec. 14, 2005 at 11:10 AM

SCHAUMBURG, Ill., Dec. 14 (UPI) -- American Pharmaceutical Partners said Wednesday it has been approved to market a generic of Pfizer's Zithromax.

APP said the Food and Drug Administration has cleared for market its azithromycin for injection, the generic equivalent of Pfizer's Zithromax.

The FDA approved the injectable generic to treat community-acquired pneumonia and pelvic inflammatory disease, when caused by susceptible microorganisms.

APP estimated 2004 sales of Pfizer's drug in excess of $69 million and more than $74 million in the first nine months of 2005, quoting statistics from IMS Health.

The generic firm said it would launch its newly approved injectable -- to be sold in 500-mg vials -- in the first quarter of 2006.

"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 Patrick Soon-Shiong, APP's chairman and CEO. "Azithromycin is the sixth multi-source product approval APP has received this year," he said.

© 2005 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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