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Ortho-McNeil's oral solution of Levaquin granted US FDA nod

Raritan, NJMonday, November 1, 2004, 08:00 Hrs  [IST]

The US FDA has approved a new, once-a-day formulation of Levaquin (levofloxacin) Oral Solution 25 mg/mL. The new liquid formulation provides a convenient option for adult patients who have trouble swallowing tablets. According to published data, as many as 1 in 17 people may experience trouble swallowing; this includes 25 per cent of all hospitalized patients, and up to 40 per cent of nursing home patients, according to a Ortho-McNeil Pharmaceutical statement. Levaquin Oral Solution is indicated to treat infections currently approved for the tablet and intravenous formulations and is effective against Staphylococcus aureus, Streptococcus pneumoniae (including all multiple drug-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. The new oral solution has the same efficacy as the tablet formulation and continues to provide the flexible dosing required for renally impaired patients. Levaquin has demonstrated safety and a low incidence of gastrointestinal and central nervous system adverse events: nausea (1.2%), diarrhoea (1.0%), insomnia (0.4%), dizziness (0.3%). The research and development supporting the approval of Levaquin Oral Solution was conducted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Ortho-McNeil Pharmaceutical, Inc, also a Johnson & Johnson company, markets Levaquin in the United States.

 
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