The FDA has approved some generic version of Johnson & Johnson’s Levaquin (levofloxacin), an antibiotic used to treat mild, moderate and severe bacterial infections for adult patients. The FDA (Food and Drug Administration) has approved generic versions in tablet, oral-solution and injectable-solution forms.

A generic drug is the same (bioequivalent) as a brand name drug in every sense – dosage form, efficacy, strength, administration route, quality, and intended use. Although chemically identical to branded drugs, generic drugs are much cheaper. Generic drugs save consumers approximately $8 to $10 billion dollars in retail pharmacies each year. Further substantial savings are made when hospitals use generic drugs.

Levofloxacin is used for treating respiratory tract infections, urinary tract infections, prostatitis, anthrax, traveler’s diarrhea, pelvic inflammatory disease, meningitis, and endocarditis. It is used to treat severe or life-threatening bacterial infections, as well as infections which have not responded to other antibiotic medications.

Keith Webber, Ph.D., deputy director, Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, said:

“Generic drugs are important options that allow greater access to health care for Americans. FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product.”

The FDA announced that the following companies’ applications for generic levofloxacin have been approved:

  • Akorn Inc.
  • Wockhardt Ltd.
  • Teva Pharmaceuticals USA
  • Aurobindo Pharma Ltd.
  • Torrent Pharmaceuticals Ltd.
  • Dr. Reddy’s Laboratories Ltd.
  • Sandoz Inc.
  • Glenmark Generics Ltd.
  • Sagent Strides LLC
  • Hi-Tech Pharmacal Co. Inc.
  • Mylan Pharmaceuticals Inc
  • Lupin Ltd.

Levofloxacin is a fluoroquinolones. All fluoroquinolones have a boxed warning telling patients and doctors that these medications may increase the risk of tendinitis and tendon rupture, especially among patients over the age of 60 years, as well as those taking corticosteroid medications. The risk is also greater for patients with heart, lung or kidney transplants. Levofloxacin may also worsen muscle weakness in patients with myasthenia gravis.

Levaquin is made by Ortho-McNeil-Janssen Pharmaceuticals, part of Johnson & Johnson.

Levaquin has been a blockbuster drug, generating billions of dollars in revenue. In 2007, it accounted for 6.5% of Johnson & Johnson’s total revenue – generating $1.6 billion.

Written by Christian Nrodqvist