Wednesday, 20 November 2019

Jubilant smoking cessation aid gets FDA nod

21 October 2013 | News | By BioSpectrum Bureau

The company said in a statement that they are proposing to launch both the drugs in the present quarter of FY 2013-14

The company said in a statement that they are proposing to launch both the drugs in the present quarter of FY 2013-14

Singapore: India's leading pharma company, Jubilant Life Sciences received an approval from the US FDA for its anti-depressant drug, Bupropion Hydrochloride.

The company said in a statement that, "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 estimated market size for both the products is said to be around $518 million annually. The company added in its statement that they are proposing to launch both the drugs in the present quarter of FY 2013-14.

The company has filed 649 applications for formulations until June, of which 189 have been approved at several places, including 58 abbreviated new drug application (ANDA) in the US and 41 dossier filings in Europe.

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