Aurobindo Pharma has received tentative approval from the US FDA to manufacture and market levofloxacin tablets 250mg, 500mg, and 750mg.

Levofloxacin tablets 250mg; 500mg and 750mg are equivalent of Ortho Mcneil Janssen Pharmaceutical Inc’s Levaquin tablets and are indicated for the treatment of adults with mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections etc. The product has a market size of nearly USD 1.45 billion for the twelve months ending September 2010 according to IMS.

Aurobindo Pharma Ltd is manufacturing facilities that are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil. The company will launch the product after final approval, and they has total of 130 ANDA approvals (99 final approvals and 31 tentative approvals) from US FDA.