The US health regulator has approved the first generic version of antibiotic Levofloxacin used for treating bacterial infections to be sold in the American market.
The move will enable 12 firms, including Aurobindo Pharma, Dr Reddy’s Laboratories, Glenmark Generics, Lupin and Wockhardt, to sell their copies in the US.
The approval is for the generic tablet, oral solution, and injectable solution dosage forms of Levofloxacin, the US Food and Drug Administration said in a statement.
“Generic drugs are important options that allow greater access to healthcare for Americans,” the USFDA Center for Drug Evaluation and Research, Office of Pharmaceutical Science Deputy Director, Mr 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. It is also used in treating certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax, the USFDA said.
“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 brandname product,” Mr Webber added.
According to IMS Health sales data, levofloxacin tablets had a market size of nearly $1.45 billion for the 12 months ended September 30, 2010.