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Drug of Indian Manufacturer Tentatively Approved by FDA

by Rathi Manohar on January 25, 2011 at 10:40 PM
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 Drug of Indian Manufacturer Tentatively Approved by FDA

The FDA in the US has tentatively approved Aurobindo Pharma to manufacture and market levofloxacin tablets in the American market.

Levofloxacin tablets 250mg, 500mg, and 750mg. are prescribed for the treatment of bacterial infections like pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections in adults.

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The company is waiting for the final approval before launching the product. It is also manufacturing facilities that are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil.



Source: Medindia
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