The US Food and Drug Administration (FDA) has granted final approval to Jubilant Life Sciences Ltd for its paroxetine tablets (in 10 mg, 20 mg, 30 mg and 40 mg strengthens). Paroxetine tablet, which is used as an antidepressant, is a generic version of Apotex’s Paxil tablet.
As on September 30, 2015, Jubilant Life Sciences had a total of 820 filings for formulations of which 391 have been approved in various regions globally. This includes 71 ANDAs filed in the US, of which 39 have been approved and 46 dossier filings in Europe.
As on September 30, 2015, Jubilant Life Sciences had a total of 820 filings for formulations of which 391 have been approved in various regions globally. This includes 71 ANDAs filed in the US, of which 39 have been approved and 46 dossier filings in Europe.