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FDA approves first generic versions of Levaquin

SILVER SPRING, Md. — The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved, the FDA said. 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.

Levofloxacin is a generic version of Levaquin, which is marketed by Ortho-McNeil-Janssen Pharmaceuticals. The following 12 manufacturer's applications for generic Lexaquin have been approved:

  • Akorn;

  • Aurobindo Pharma;

  • Dr. Reddy's Labs;

  • Glenmark Generics;

  • Hi-Tech Pharmacal;

  • Lupin;

  • Mylan Pharmaceuticals;

  • Sagent Strides;

  • Sandoz;

  • Teva Pharmaceuticals;

  • Torrent Pharmaceuticals; and

  • Wockhardt.

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