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news.Barr Pharmaceuticals and its subsidiary Pliva have received final approval from the FDA to manufacture and market azithromycin, the generic version of Pfizer's Zithromax.
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The company intends to launch its product during the first quarter of 2007.
Azithromycin for injection is indicated for the treatment in patients who require intravenous therapy for infections caused by susceptible strains of the designated microorganisms in community-acquired pneumonia and pelvic inflammatory disease. An antimicrobial agent with anaerobic activity should be administered in combination with Zithromax if appropriate.
Azithromycin will compete in a market that had total US sales of approximately $75 million, based on IMS data for the 12-month period ending November 2006.