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RARITAN, N.J. -- Ortho-McNeil Pharmaceutical, Inc., announced today it is seeking marketing approval from the U.S. Food and Drug Administration (FDA) for a five-day, once-daily regimen for LEVAQUIN (levofloxacin) tablets/injection and LEVAQUIN (levofloxacin in 5 percent dextrose) Injection to treat mild-to-severe community-acquired pneumonia (CAP).
The supplemental new drug application submitted to the FDA is based on a multi-center, randomized, double-blind study of 528 outpatients and hospitalized adults with mild-to-severe CAP. LEVAQUIN currently has a seven- to 10-day indication to treat mild-to-severe CAP. If approved at a five-day dosing schedule, LEVAQUIN would be the first anti-infective indicated for a once-daily, short-course regimen to treat CAP.
CAP is an inflammation of the lungs due to infection and the No. 1 cause of death from infectious disease in the United States each year. It affects up to 4 million people in the United States resulting in approximately $23 billion annually in related medical costs.
LEVAQUIN is dosed once daily and indicated for a wide variety of infections including nosocomial pneumonia, mild-to-moderate cases of complicated urinary tract infections, acute pyelonephritis, uncomplicated urinary tract infections, acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis. 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.
Ortho-McNeil Pharmaceutical, Inc., has marketed LEVAQUIN in the United States since January 1997. Ortho-McNeil, a Johnson & Johnson company, is based in Raritan, NJ. The company markets pharmaceutical products in several therapeutic categories including infectious diseases, central nervous system, wound healing, urology and women's health.
Source: Ortho-McNeil Pharmaceutical, Inc.