BARR WINS FDA APPROVAL FOR GENERIC ZITHROMAX, TENTATIVE APPROVAL FOR GENERIC KYTRIL

Barr Pharmaceuticals and its subsidiary Pliva have won final FDA approval to manufacture and market injectable azithromycin, a generic version of Pfizer's Zithromax.

Barr said the approved abbreviated new drug application to market its generic version of azithromycin in 500-mg vials lets Pliva compete in a market that had total U.S. sales of approximately $75 million last year, according to IMS Health data for the 12-month period ended November 2006.

Azithromycin is used for the treatment of patients who require intravenous therapy for infections caused by susceptible strains of certain microorganisms due to:Community-acquired pneumonia from Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae; or Pelvic inflammatory disease from Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis.

The FDA has also given Barr tentative approval to market granisetron hydrochloride, a generic version of Roche's Kytril, a drug used for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy.