Barr Pharmaceuticals, Inc. and its subsidiary Pliva d.d. announced that Pliva has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Azithromycin for injection, 500 mg vial, the generic version of Pfizer Labs' Zithromax IV (azithromycin for injection). 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: 1) Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae; and 2) Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis. An antimicrobial agent with anaerobic activity should be administered in combination with Zithromax if appropriate.

The company's Azithromycin for Injection, 500 mg vial 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.