US FDA grants approval to Jubilant's hypertension drug felodipine
The approved product, felodipine extended-release tablet (2.5 mg, 5 mg, and 10 mg), is the generic version of Plendil tablets of AstraZeneca
Jubilant Life Sciences Ltd has received final approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for felodipine extended-release tablet (2.5 mg, 5 mg, and 10 mg). The approved product is the generic version of Plendil tablets of AstraZeneca, which is used for the treatment of hypertension.
As on June 30, 2016, Jubilant Life Sciences had a total of 770 filings for oral solids of which 578 have been approved in various regions globally. This includes 70 ANDAs filed in the US, of which 44 have been approved and 104 filings in Europe.