Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it 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, Inc.’s 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, 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.
Paxil CR® had US sales of USD 127.4 million (IMS MAT June 2016).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 5th largest generics player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2nd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).
For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Corporate Communications
Ph: +91-98 20 338 555
Paxil CR® is the registered trademark of GlaxoSmithKline LLC Limited.