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Levaquin (Levofloxacin) Receives FDA Approval for 5-Day Treatment of Community Acquired Pneumonia

RARITAN, NJ -- October 24, 2003 -- The U.S. Food and Drug Administration (FDA) has approved a new 5-day dosage form of LevaquinŽ (levofloxacin) Tablets/Injection and LevaquinŽ (levofloxacin in 5% dextrose) Injection 750mg once-daily regimen to treat mild-to-severe community acquired pneumonia (CAP). With this approval, Levaquin becomes the only short-course fluoroquinolone indicated to treat CAP in a 5-day regimen.

"In an effort to address bacterial resistance, the World Health Organization (WHO) Antimicrobial Resistance Guidelines have called for aggressive, short-courses of therapy," said Thomas M. File, Jr., M.D., Northeastern Ohio Universities College of Medicine. "Levaquin 750mg meets these guidelines because it is highly efficacious, well tolerated, and treats CAP in half the time of the standard 500mg regimen."

The 5-day Levaquin treatment leads to 25 percent less exposure to the drug over the course of treatment and may help prevent resistance caused by antibiotic overexposure. Results from the clinical trial for the short-course therapy of CAP demonstrated that Levaquin 750mg for five days produced similar clinical cure rates to the longer 10-day course of Levaquin 500mg. In addition, the study found no increase in adverse events with the 750mg dose of Levaquin. In the clinical trial more than 99 percent of the bacteria isolated were susceptible to Levaquin.

"This new regimen for Levaquin means that a five-day course of therapy for CAP is as effective as current longer courses of therapy," said Thomas Slama, Clinical Professor of Medicine, Indiana School of Medicine. "The advantages of shorter courses of therapy should be obvious; the possibility of improved patient compliance, lower drug exposure that may reduce development of bacterial resistance, and a continued excellent safety profile."

CAP is the sixth leading cause of death in the United States, and the number one cause of death from infectious disease. Characterized by an inflammation of the lungs due to infection, as many as two million cases of CAP are diagnosed in the United States each year, accounting for 10 million doctor's visits. Approximately 500,000 patients require hospitalization. The economic cost of treating patients with CAP is $8 billion annually.

The comparable bioavailability of Levaquin injection and tablets allows for the use of the same dose of treatment in both inpatient and outpatient settings.

Levaquin is dosed once-daily and indicated for a wide variety of infections including, community-acquired pneumonia, nosocomial pneumonia, mild to moderate cases of complicated urinary tract infections, acute pyelonephritis, uncomplicated urinary tract infections, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and chronic bacterial prostatitis. The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions often occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should be taken at least two hours before or two hours after levofloxacin administration. For more information on warnings, precautions, and additional adverse reactions that may occur, regardless of drug relationship, please see accompanying full U.S. Prescribing Information or visit http://www.levaquin.com or http://www.ortho-mcneil.com.

More than 250 million patients have been treated with levofloxacin worldwide since 1993.

*Videx is a registered trademark of Bristol-Myers Squibb Company


SOURCE: Ortho-McNeil Pharmaceutical, Inc.

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