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Jubilant Life Sciences receives ANDA approval

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Spironolactone is  the generic version of Aldactone®(of GD Searle)
 
Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for Spironolactone Tablets, 25 mg, 50 mg and 100 mg. Spironolactone, is  the generic version of Aldactone®(of GD Searle), which is used as a diuretic to treat fluid retention (edema) caused by congestive heart failure and cirrhosis of the liver. The product is expected to be launched in Q1 FY15.The total market size for Spironolactone Tablets as per IMS is $87million per annum.
 
Jubilant has also received a tentative approval from the USFDA for Memantine Tablets, 5 mg and 10 mg, the generic version of Namenda® (of Forest Labs), which is used for treatment of moderate-to-severe Alzheimer’s disease. It is expected to be launched post patent expiry in 2015. The total market size for Namenda®as per IMS is $1.85billion per annum.
 
As on December 31, 2013, Jubilant Life Sciences had a total of 689 filings for formulations, of which 230 have been approved in various regions globally. This includes 60 ANDAs filed in the US and 42 Dossier filings in Europe.
 
 
EP News Bureau Mumbai

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