FDA NEWS RELEASE
For Immediate Release: June 20, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections
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, especially in those older than 60, in patients taking corticosteroid drugs, and in those with kidney, heart, or lung transplants. The boxed warning also contains an alert that the drug may worsen muscle weakness in people with myasthenia gravis, a chronic autoimmune neuromuscular disease.
Levofloxacin must be dispensed with a patient Medication Guide that describes the drug’s uses and warnings.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.