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FDA approves first generic US versions of levofloxacin

On June 20, 2011, the U.S. Food and Drug Administration (FDA) approved a cover letter from 12 pharmaceutical companies for the production of generic versions of levofloxacin fluoroquinolone (Levaquin, Levaquin, Ortho-McNeil-Janssen Pharmaceuticals, division of the global company Johnson & Johnson).

Companies, including Teva Pharmaceutical and Sandoz Inc., are starting production of generic levofloxacin because the levofloxacin patent for Johnson & Johnson has expired. The original levofloxacin was a very popular and financially effective drug for the business. Thus, in the United States, sales of levaquine in 2010 amounted to $ 1.3 billion, and in the first quarter of 2011 - $ 422 million.

Levofloxacin is the second drug in the fluoroquinolone group, which will be available in generic form. Currently, there are also generics of another no less popular fluoroquinolone - ciprofloxacin (Cipro, Cipro, Bayer). The patent for the third drug in this group - moxifloxacin (Avelox, Avelox, Schering Corp, a division of Merck & Co) expires in December 2011.

Levofloxacin is used in the United States to treat moderate to severe infections of the skin, ENT organs, kidneys, bladder, and prostate caused by susceptible microorganisms. In addition, the drug can be used to treat lower respiratory tract infections, including bronchitis and pneumonia, as well as the inhaled form of anthrax.

In 2008, the FDA issued a strict warning (black box warning - in the instructions for the drug, the warning is placed in a black box, a sign of a particular severity of the warning) for all fluoroquinolones, which was directed to both prescribing physicians and patients, in which it was stated that fluoroquinolones may lead to an increased risk of tendonitis and tendon rupture. Between November 1997 and December 2005, the FDA reported 262 cases of tendon rupture in patients treated with fluoroquinolones. According to data provided by the FDA, the risk of tendon rupture is higher in the elderly, especially in patients over the age of 60 who take glucocorticoids, as well as in people who have had a kidney transplant, heart or lung. The warning also indicates that fluoroquinolones can cause muscle weakness in patients with myasthenia gravis (a chronic autoimmune neuromuscular disease).

Leading experts from the FDA point out that generic drugs must meet strict standards and be of high quality to guarantee the same effect for doctors and patients as the brand name drug.

Generic versions of levofloxacin (tablets, oral solution and parenteral solution) are approved for the following 12 companies: