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Lupin 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 the treatment of major depressive disorders, panic disorders, social anxiety disorders and premenstrual dysphoric disorders.
Citing IMS MAT data till June 2016, Lupin said Paxil CR had US sales of $127.4 million.
Shares of Lupin were trading down by 0.46 per cent at Rs 1,515.60 on the BSE.
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