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Lupin receives tentative approval for generic Paxil CR tabs

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It is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder

Lupin has received tentative approval for its Paroxetine extended-release tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies’ Paxil CR tablets, 12.5 mg, 25 mg and 37.5 mg.

Lupin’s Paroxetine extended-release tablets USP, 12.5 mg, 25 mg and 37.5 mg are the AB rated generic equivalent of Apotex Technologies’ Paxil CR tablets, 12.5 mg, 25 mg and 37.5 mg. It is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

Paxil CR had US sales of $127.4 million (IMS MAT June 2016).

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