PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for manufacture and market Azithromycin for Injection, 500 mg vial, the generic version of Pfizer Labs' ZITHROMAX(R) IV (azithromycin for injection).
The Company intends to launch its product during the first quarter of 2008.
Azithromycin (the trade name Zithromax) which is dozed as a disposable - unique oral antibiotic, is to comparable other frequently ordered treatment for some of the most common respiratory infections of the treatise in adult patients. Azithromycin was accessible in the United States with 1992 under tradename Zithromax. Pfizer sponsored studying and has presented the data for the review the American FDA. The company searches for approval treatment of adult respiratory infections of the treatise, including sharp bacterial amplifications of a chronic bronchitis sharp bacterial sinusitis, and the community got a pneumonia.
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 due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae;
- 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 U.S. sales of approximately $72 million, based on data for the 12-month period ending November 2007.
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