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The US health regulator has provided its tentative approval to the pharma major Lupin for its generic version of anti-depressant Paroxetine extended-release tablets.
Lupin has said in a BSE filing that the tentative approval by the United States Food and Drug Administration (USFDA) is for multiple strengths of 12.5 mg, 25 mg and 37.5 mg of the generic version of Apotex Technologies’ Paxil CR tablets of similar strengths.
The drug has been indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.
