Jubiliant secures USFDA approval for two generic drugs
The company aims to launch the products by Q3 FY14.
New Delhi, October 18, 2013: Indian drug firm Jubiliant Life Sciences has received approval from the US Food and Drug Administration (USFDA) to market generic versions of GlaxoSmithKline’s anti-depressant Wellbutrin SR and smoking cessation aid, Zyban.
It is important to note that the abbreviated new drug applications (ANDAs) approval bupropion hydrochloride extended-release tablets, the generic version of Wellbutrin SR, is in multiple strengths of 100 mg, 150 mg and 200 mg.
The company also added in the BSE filing that for bupropion hydrochloride extended-release tablets, the generic version of Zyban, the approval is for 150 mg. The company aims to launch these products by Q3 FY14.
The total market size for these products in the US is estimated at US$ 518 million per annum. It is significant to note that Jubilant Life Sciences had a total of 649 filings for formulations, including 58 ANDAs filed in the US and 41 Dossier filings in Europe, as on June 30, 2013. Of these, 189 have been approved in various regions of the world.