Six Indian pharma majors are set to enter the United States generic market for Levaquin (levofloxacin), an antibiotic approved for treating bacterial infections.
Oral and injectable forms of levofloxacin have been approved from 12 manufacturers, including six Indian companies — Aurobindo, Dr Reddy's, Glenmark, Lupin, Torrent and Wockhardt.
Levaquin reported annual sales of $1.3 billion in 2010 and $422 million in the first quarter of 2011.
In July 2008, the US Food and Drug Administration (FDA) notified the manufacturers of fluoroquinolone drugs such as levaquin and ciprofloxacin, that a black box warning about the risk of tendon ruptures and tendonitis were required. The risk is greater among older people (above 60), patients taking corticosteroid drugs and those who had kidney, heart or lung transplants. According to the FDA statement, the warning should state that the drug may increase muscle weakness in people with myasthenia gravis, a chronic autoimmune neuromuscular disease.
"The Indian players have nothing to cheer, since the margin will be below 10 per cent, that is due to the competition in the generic space," noted a Mumbai-based pharma analyst.
Levofloxacin is used to treat mild, moderate or severe bacterial infections of the skin, sinuses, kidneys, bladder and prostate caused by specific germs, and those which causes bronchitis or pneumonia. It is used to treat those exposed to inhalational anthrax.
"FDA-approved generic drugs must meet rigorous standards and are required to be of high quality,” said Keith Webber, Deputy Director Pharmaceutical Science, USFDA's Center for Drug Evaluation and Research.
