Jubilant Life Sciences receives ANDA approval for Levofloxacin tabs

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It is used for the treatment of adults with infections such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Levofloxacin tablets, 250mg and 500mg, the generic version of Levaquin Tablets (of Ortho-McNeil). It is used for the treatment of adults with infections such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax. The total market size for Levofloxacin tablets as per IMS is $28 Million per annum.

As on March 31, 2015, Jubilant Life Sciences had a total of 806 filings for formulations of which 368 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe.

ANDAJubilant Life sciencesLevofloxacin tabletsUS FDA