Indian major pharma companies are nearly entering the Unites States generic market to sell the antibiotic Levaquin-levofloxacin which is used to treat bacterial infections.
FDA has approved 12 companies to sell levofloxacin including six Indian companies- Aurobindo, Dr Reddy’s, Glenmark, Lupin, Torrent and Wockhardt.
The tablets of levofloxacin will be available in the strength of 250mg, 500mg and 750mg.
Levofloxacin is a generic version of levaquin.
FDA also notified the manufacturers to state the warning about its side effects like muscle weakness, tendon ruptures and autoimmune neuromuscular disease.
Levofloxacin is generally used to treat mild, moderate and severe bacterial infections of many diseases like skin, kidneys, bladder and sinuses. It is also being used to treat pneumonia.
“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.
http://myhealthbowl.com/latest-health-news/fda-approves-six-indian-pharma-companies-for-selling-anti-biotic-levofloxacin-in-u-s/
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Thursday, June 23, 2011
FDA approves six Indian pharma companies for selling anti-biotic levofloxacin in U.S.
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