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FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections

SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.


Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.

"Generic drugs are important options that allow greater access to health care for Americans," said Keith Webber, Ph.D., deputy director, Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "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."

Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved. The following 12 manufacturer's applications for generic levofloxacin have been approved:

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

Levofloxacin belongs to a class of drugs called fluoroquinolones. All fluoroquinolones have a boxed warning alerting prescribers and patients that these products are associated with an increased risk of tendinitis and tendon rupture. The risk is greater in older people,

SOURCE U.S. Food and Drug Administration
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