Lupin receives US FDA nod for anti-depressant drug paroxetin

The approved product is the generic version of Apotex Technologies' Paxil CR tablet

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BS B2B Bureau Mumbai

Last Updated : Jan 24 2017 | 11:41 AM IST

Lupin Limited has received final approval for its anti-depressant drug - paroxetin extended release (ER) tablet in strengthens of 12.5 mg, 25 mg and 37.5 mg - from the US Food and Drug Administration (FDA). The company plans to commence promotion of the product shortly.

The approved product is the generic version of Apotex Technologies’ Paxil CR tablet, which had US sales of $ 127.7 million, according to IMS MAT September 2016 data.

Lupin’s paroxetin extended release tablet is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.