Jubilant Life Sciences gets USFDA nod for generic drugs

NEW DELHI: Jubilant Life Sciences today said it has received US health regulator's approval to market generic version of GD Searle's Aldactone, used to treat fluid retention, in the American market.

The company has 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, the generic version of GD Searle's Aldactone, Jubilant Life Sciences said in a statement.

"We expect to launch this product in Q1 FY15. The total market size for Spironolactone tablets as per IMS is $87 million per annum," it added.

The company said it has also received USFDA's nod for a generic version of Forest Labs' Namenda, used to treat Alzheimer's disease. It received approval to market Memantine tablets in strengths of 5 mg and 10 mg in the US market.

"We expect to launch this product post patent expiry in 2015. The total market size for Namenda as per IMS is $1.85 billion per annum," the company said.

As on December 31, 2013, Jubilant 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.

Jubilant Life Sciences shares today closed at Rs 166.85 apiece on the BSE, down 3.33 per cent from previous close.