Lupin receives FDA approval for generic Wellbutrin XL tabs

The filing was done from Lupin’s Goa manufacturing facility and it will available in 150 mg and 300 mg capsules

Lupin received approval for its Bupropion Hydrochloride Extended-Release tablets USP (XL), 150 mg and 300 mg from the US 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’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 $755 million according to IMS MAT December 2016.