American Pharmaceutical gets FDA OK for Azithromycin for Injection, generic of Pfizer's Zithromax

By E. Janene Geiss

Philadelphia, Dec. 14 - American Pharmaceutical Partners, Inc. announced Wednesday that it has received approval from the Food and Drug Administration for its Abbreviated New Drug Application for Azithromycin for Injection, the generic equivalent of Pfizer Inc.'s Zithromax.

Sales of this product exceeded $69 million in 2004 and were more than $74 million through the first nine months of 2005 as recorded by IMS, company officials said in a news release.

The company said it expects to start marketing Azithromycin in the first quarter of 2006, with GPO contracts in place.

"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, chairman and chief executive officer, in the release.

The company said Azithromycin is the sixth multi-source product approval it has received this year. It will be available in 500 mg vials, is preservative-free and AP rated. Each vial will include a bar code and latex-free vial stopper.

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

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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