Jubilant Life Sciences receives ANDA approval for Paroxetine Tablets

Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg and 40 mg, the generic version of Paxil Tablets, 10 mg, 20 mg, 30 mg, and 40 mg® (of Apotex), which is used as an antidepressant.

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.

Jubilant Pharma Pact with Cyclopharm

Jubilant Life Sciences said its subsidiary Jubilant DraxImage Inc has signed a term sheet with Australia based Cyclopharm for exclusive licence to market Technegas in the United States.

Technegas is an imaging agent primarily used in Pulmonary Embolism. DraxImage will assist CYC with the development and financing of the Phase III clinical trials for Technegas, and any other steps required to file for and obtain US FDA approval.

The company said in a statement that DraxImage will provide at risk up to $4.5 million to fund the USFDA clinical trial currently under development with any additional costs to be funded by both parties equally.