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FDA approval for azithromycin


Azithromycin for injection (500mg vial), a generic version for Pfizer’s Zithromax, has received final FDA approval of its additional new drug application (ANDA).

Pliva (Barr Pharmaceuticals), who will market the generic drug, intends to launch it during the first quarter of 2007. The drug is indicated for the treatment of patients who require intravenous therapy for infections caused by susceptible strains of the designated microorganisms in community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae, as well as pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis.

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