Lupin receives FDA approval for generic Wellbutrin XL Tablets
The filing is from Lupin’s Goa manufacturing facility
Mumbai, April 08, 2017: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bupropion Hydrochloride Extended-Release tablets USP (XL), 150 mg and 300 mg from the United States Food and Drug Administration (FDA) to market a generic version of Wellbutrin XL® tablets, 150 mg and 300 mg.
Lupin’s Bupropion Hydrochloride Extended-Release tablets USP (XL), 150 mg and 300 mg are the AB rated generic equivalent of Valeant Pharmaceuticals North America, LLC’s Wellbutrin XL® tablets, 150 mg and 300 mg. It is indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD) in adults.
Wellbutrin XL® tablets had US sales of USD 755 million (IMS MAT December 2016).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering 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 and the 6th largest generics pharmaceutical company by market capitalization (December 31st, 2016, Bloomberg) and sales globally (September 30th, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.3% market share — IMS MAT December 2016); the 2nd largest Indian pharmaceutical company by revenues; the 6th 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.
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