Jubilant Life Sciences receives ANDA approval for Spironolactone Tablets

Also gets tentative ANDA approval for Memantine Tablets

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for Spironolactone Tablets, 25 mg, 50mg and 100 mg, 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 US$ 87 million 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. The product is expected to be launched post patent expiry in 2015.

The total market size for Namenda as per IMS is US$ 1.85 Billion per annum.

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