Aurobindo Pharma Limited has bagged tentative nod from the US Food & Drug Administration to make and sell Levofloxacin tablets in the American market.
The company bagged nod to manufacture and market the drug, the generic equivalent of Ortho McNeil Janssen Pharmaceutical Inc's Levaquin pills, in the potencies of 250mg, 500mg and 750mg.
Levofloxacin pills 250mg, 500mg, and 750mg are suggested to cure bacterial illnesses including chronic bronchitis, bacterial sinusitis, pneumonia, skin and skin structure diseases in grownups.
Aurobindo Pharma is looking for the final nod before rolling out the product.
It is also constructing plants that are sanctioned by several major regulatory agencies such as US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil.
Levofloxacin tabs covered a market size of around US1.45 billion for the twelve month period ended September 2010.
Presently, the pharma giant has around 130 ANDA authorizations (99 Final approvals and 31 Tentative approvals) from the US FDA.
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