Tuesday 7 July 2015

ANDA to Jubilant Life Sciences



On June 23, 2015, Jubilant Life Sciences Ltd. received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Levofloxacin Tablets, 250mg and 500mg. Now Jubilant may manufacture and market the generic drug to the American Public.

Jubilant Life Sciences is an integrated global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Specialty Pharmaceuticals and Life Science Ingredients.

The drug Levofloxacin is the generic version of Levaquin Tablets® (of Ortho-McNeil), which 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 a total of 806 filings for formulations as on March 31, 2015, out 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.

Source: http://www.jubl.com/media-press-details.aspx?mpgid=73&pgid=74&pressid=252

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