Drug firm Jubilant Life Sciences has received final approval from the US health regulator for generic anti-hypertensive Valsartan tablets and the company plans to launch the product immediately.
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Valsartan tablets USP in the strengths of 40 mg, 80 mg, 160 mg and 320 mg, Jubilant Life Sciences said in a filing to BSE.
“We expect to launch this product immediately,” it added.
The product is generic version of Diovan tablets of pharma major Novartis and is used as an anti-hypertensive, Jubilant Life Sciences said.
“The current annualised US market size for Valsartan tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg as per IMS is $2 billion,” it added.
As on September 30, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the U.S. and 46 dossier filings in Europe, Jubilant Life Sciences said.
Shares of Jubilant Life Sciences closed at Rs 144.85 on BSE, up 3.69 per cent over previous close.