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FDA approves generic versions of levofloxacin for certain infections
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The FDA approved the first generic versions of levofloxacin, an antibiotic approved to treat certain infections in those aged 18 and older, according to an FDA press release.
Levofloxacin (Levaquin) is for the treatment of mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific bacteria. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax, according to the release.
“Generic drugs are important options that allow greater access to health care for Americans,” Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
Approved forms of levofloxacin include tablet, oral solution, and injectable solution dosage:
- 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 must be dispensed with a patient Medication Guide, according to the FDA.
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