Lupin Receives FDA Approval For Generic Wellbutrin XL Tablets


Pharma Major Lupin Limited (Lupin) announced on Monday, 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).

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. 

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