To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: LEVAQUIN Anti-Infective for Three Respiratory Diseases Cleared by FDA URL: http://www.pslgroup.com/dg/20532.htm Doctor's Guide December 21, 1996
RARITAN, N.J., Dec. 21, 1996 -- LEVAQUIN(TM) tablets/injection (levofloxacin tablets/injection), the first once-a-day anti-infective proven effective against three of the most difficult to treat bacterial respiratory infections, has been cleared for marketing by the U.S. Food and Drug Administration. LEVAQUIN is indicated for the treatment of adults with community-acquired pneumonia, acute maxillary sinusitis or acute exacerbation of chronic bronchitis, which, collectively affect more than 50 million people each year. "LEVAQUIN is the first anti-infective indicated to treat all the key respiratory pathogens," said Thomas File, M.D., professor of internal medicine, Northeastern Ohio Universities College of Medicine, Akron, and a clinical investigator for LEVAQUIN. "Clinical trials demonstrated that LEVAQUIN was more effective than the current standard of therapy for community-acquired pneumonia." More than 3,450 patients on LEVAQUIN participated in the clinical trials. The pivotal studies proved that LEVAQUIN was: * More effective in the treatment of community-acquired pneumonia compared to combination therapies of Rocephin and/or Ceftin, with or without erythromycin; * As effective in the treatment of sinusitis as Augmentin with fewer daily doses and fewer gastrointestinal side effects (12 percent incidence of drug-related diarrhea with Augmentin versus one percent with LEVAQUIN); * As effective in the treatment of acute exacerbation of chronic bronchitis as Ceftin or Ceclor with fewer daily doses over a shorter period of treatment. The clinical trials also indicated LEVAQUIN is well tolerated by patients and has a favorable safety profile. The most common drug-related side effects were nausea (1.2 percent) and diarrhea (1.2 percent). Less than 0.1 percent of patients experienced phototoxicity (sensitivity to sunlight); 1.3 percent experienced drug-related central nervous system side effects, with dizziness and insomnia being the most common at .3 percent. LEVAQUIN can be taken with food and can be used by patients who are allergic to penicillin or intolerant of macrolides. "Compared to many traditional anti-infective agents, LEVAQUIN offers significant advantages to patients and their physicians," said James B. Kahn, senior director, infectious disease research and clinical affairs, Ortho-McNeil Pharmaceutical. "Its safety and efficacy have been established in a wide range of community-acquired infections and it's administered only once-a-day. The convenience of this simple regimen should mean greater ease of patient compliance." LEVAQUIN is also indicated for uncomplicated skin and skin structure infections, complicated urinary tract infections and acute pyelonephritis (kidney infection). It will be available in January in both intravenous and tablet form. The safety and efficacy of levofloxacin in children, 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 other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. For information on warnings, precautions and additional adverse reactions that may occur, please see full prescribing information which is attached. LEVAQUIN will be marketed in the United States by Ortho-McNeil Pharmaceutical of Raritan, N.J., a Johnson & Johnson company. Ortho-McNeil manufactures and markets pharmaceutical products in several therapeutic categories including women's health, central nervous system and infectious diseases. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.