Jubilant gets US FDA nod for anti-depressant drug
Leading pharma firm Jubilant Life Sciences received approval from the US Food and Drug Administration (FDA) for its anti-depressant drug Bupropion Hydrochloride, the company said Friday.
"We have also received approval for the same extended drug used as smoking cessation aid. Both formulations are generic version of GlaxoSmithKline's Wellbutrin and Zyban tablets respectively," the company said in a statement here.
The market size for the twin products is estimated to be around USD 518 million annually.
"We propose to launch both the drugs in this quarter of 2013-14," the statement said.
The company has filed 649 applications for formulations till June, of which 189 were approved in different geographies the world over, including 58 abbreviated new drug application (ANDA) in the US and 41 dossier filings in Europe.
With 10 production facilities across India, Canada and the US, Jubilant manufactures and supplies active pharmaceutical ingredients (APIs), generics, specialty pharmaceuticals and life science ingredients, besides providing services in contract manufacturing and drug discovery and development.
(Posted on 18-10-2013)