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.
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