Jubilant gets FDA approval for antidepressant generic

December 02, 2015 | Wednesday | News | By BioSpectrum Bureau

Jubilant gets FDA approval for antidepressant generic

Jubilant's drug is the generic version of Apotex's Paxil tablets

Jubilant's drug is the generic version of Apotex's Paxil tablets

Jubilant Life Sciences 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 tablets are 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.

 

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