FDA Approves First Generic Versions of Levofloxacin

Tinker Ready

June 21, 2011

June 21, 2011 — The US Food and Drug Administration (FDA) yesterday approved applications from 12 companies to manufacture generic versions of levofloxacin (Levaquin, Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson), a widely used fluoroquinolone antibiotic.

The companies, including Teva Pharmaceutical and Sandoz Inc, will start producing generic levofloxacin now that Johnson & Johnson's patent has expired. The drug has been a blockbuster for the company. In the United States, Levaquin had sales of $1.3 billion in 2010 and $422 million in the first quarter of 2011, according to news sources.

Levofloxacin is the second common drug in its class to become available in generic form. Another fluoroquinolone, ciprofloxacin (Cipro, Bayer) is also available generically. The patent for a third drug in the same class, moxifloxacin (Avelox, Schering Corp, a subsidiary of Merck & Co), expires in December.

Levofloxacin, according to the FDA, is used for "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."

In 2008, the FDA issued a black box warning for all fluoroquinolones "alerting prescribers and patients that these products are associated with an increased risk of tendinitis and tendon rupture." The black box warning, which strengthened the original label's warning, was added after the consumer group Public Citizen petitioned the FDA. Public Citizen reported that from November 1997 through December 31, 2005, patients using fluoroquinolones reported 262 cases of tendon rupture to the FDA.

The drug is the subject of thousands of related product liability lawsuits. Last week, a federal jury in Minneapolis ruled in favor of the company in one of the cases, which have been consolidated in federal court. The company has argued that warnings about the drug are clear and cases of ruptured tendons are rare. The court ruled against the company in an early suit, and other related cases are still pending, according to Bloomberg News.

According to the FDA's warning, the risk for tendon rupture "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 warning also notes that the drug may cause muscle weakness in patients with myasthenia gravis, a chronic autoimmune neuromuscular disease.

Keith Webber, PhD, deputy director, Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, said that 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 tablets, oral solution, and injectable solution formulations of levofloxacin have been approved for the following companies:

  • 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


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