Jubilant receives USFDA approval for two generic drugs

NEW DELHI: Drug firm Jubilant Life Sciences Ltd today said it has received approval from the US Food and Drugs Administration ( USFDA) to market generic versions of GlaxoSmithKline's anti-depressant Wellbutrin SR and smoking cessation aid, Zyban.

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, Jubilant Life Sciences said in a filing to the BSE.

For bupropion hydrochloride extended-release tablets, the generic version of Zyban, the approval is for 150 mg, the company added.

"We expect to launch these products in Q3 FY'14," it said.

Quoting IMS data, the company said the current total market size of these products in the US is USD 518 million per annum.

As on June 30, 2013, Jubilant Life Sciences had a total of 649 filings for formulations, including 58 ANDAs filed in the US and 41 Dossier filings in Europe.

Of these, 189 have been approved in various regions of the world, the company said.

Shares of Jubilant Life Sciences were trading at Rs 75.25 apiece, down 0.13 per cent from their previous close on the BSE.