Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the US Food & Drug Administration to manufacture and market Levofloxacin tablets 250mg, 500mg and 750mg. Levofloxacin tablets 250mg, 500mg and 750mg are the generic equivalent of Ortho McNeil Janssen Pharmaceutical Inc’s Levaquin® tablets 250mg, 500mg and 750mg. Levofloxacin tablets are indicated for the treatment of adults with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax. The product has a market size of approximately US$ 1.45 Billion for the twelve months ending September 2010 according to IMS.
Aurobindo would launch the product immediately after final approval. Aurobindo now has a total of 130 ANDA approvals (99 Final approvals and 31 Tentative approvals) from USFDA.