NEW DELHI, Aug 26: Pharma major Lupin today said it has received tentative approval for its generic version of anti-depressant Paroxetine extended-release tablets from the US health regulator.
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, Lupin said in a BSE filing.
The drug is indicated for treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.
Citing IMS MAT data till June 2016, Lupin said Paxil CR had US sales of USD 127.4 million.
PTI)
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