FDA APPROVES PLIVA'S GENERIC ZITHROMAX IV

Barr Pharmaceuticals announced that its subsidiary Pliva has received final approval from the FDA for its abbreviated new drug application to manufacture and market azithromycin for injection, 500 mg.

The drug is the generic version of Pfizer's Zithromax IV, an antibiotic. Pliva intends to launch its product during the first quarter.

Azithromycin for injection is indicated for the treatment of patients who require intravenous therapy for: community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae; and pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis.

Pliva's product will compete in a market that had total U.S. sales of approximately $75 million, based on IMS data for the 12-month period ending in November 2006.