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 (USFDA) to market a generic version of Apotex Technologies, Inc.’s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg. As per IMS MAT June 2016, Paxil CR had US sales of $127.4 million.
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, Inc.’s 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.
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally.
