Ortho-McNeil Pharmaceutical, Inc. has filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for marketing approval of fluoroquinolone Levaquin (levofloxacin tablets/injection) in the treatment of nosocomial (hospital-acquired) pneumonia.
If approved, Levaquin would be the first of the newer respiratory fluoroquinolones to be indicated for nosocomial pneumonia. The FDA's standard time of review for sNDAs is approximately 12 months.
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.
Levaquin is the only antimicrobial indicated to treat community-acquired pneumonia (CAP) due to penicillin-resistant S. pneumoniae (MIC value for penicillin greater than or equal to 2 micrograms/mL). In addition, Levaquin is indicated to treat mild, moderate and severe cases of CAP caused by certain other pathogens, acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis. Levaquin is administered at 500 mg once daily for these respiratory infections. Additionally, Levaquin is indicated to treat mild to moderate cases of complicated urinary tract infections, acute pyelonephritis and uncomplicated urinary tract infections, at a dose of 250 mg once daily.
Levaquin is also indicated for the treatment of mild to severe cases of complicated skin and skin structure infections at a dose of 750 mg once daily, and mild to moderate cases of uncomplicated skin and skin structure infections, at a dose of 500 mg once daily.
Resistance to Levaquin is rare among respiratory pathogens according to an ongoing study in the United States and around the world. Responsible and appropriate use of all antibiotics is recommended so that emergence of antibiotic-resistant strains of bacteria is minimized.
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.