The US health regulator has approved the first generic version of anti-biotic Levofloxacin used for treating bacterial infections to be sold in the American market.
The move will enable 12 firms,including India's Aurobindo Pharma, Dr Reddy's Laboratories, Glenmark Generics, Lupin and Wockhardt, to sell their copies in the US and tap a market for the drug which stood at $1.45 billion for 12 months ending September, 2010.
The approval is for the generic tablet, oral solution, and injectable solution dosage forms of Levofloxacin, US Food and Drug Administration said in a statement.
"Generic drugs are important options that allow greater access to health care for Americans," USFDA's Center for Drug Evaluation and Research, Office of Pharmaceutical Science deputy director Keith Webber said.
Daiichi Sankyo has the patent for Levofloxacin. It is sold under the Levaquin brand.
Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs, USFDA said.
It is also used in treating certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax, it added.
"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," Webber added.
According to IMS Health sales data, levofloxacin tablets had a market size of nearly $1.45 billion for the 12 months ending September, 2010.