Essays

Six Indian firms to enter the US generic drug market

Category : Essays

Six Indian pharma majors will be entering the US 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.

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 - Center for Drug Evaluation and Research. Dr Reddy's and Lupin have announced the launch of the tablets in the strengths of 250 mg, 500 mg and 750 mg.


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