Jubilant Life Sciences announced that it has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, the generic version of Diovan (of Novartis), used as an anti-hypertensive.
"We expect to launch this product immediately. The current annualized US market size for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg as per IMS is USD 2 billion," the company said.
As on Sept. 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 US and 46 Dossier filings in Europe.
Shares of the company gained Rs 5.15, or 3.69%, to settle at Rs 144.85. The total volume of shares traded was 445,625 at the BSE (Tuesday).