Lupin gets USFDA nod for drug

Pharma major Lupin has received final approval from the USFDA for Bupropion Hydrochloride tablets used for the treatment of major depressive disorder.

Lupin 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 (USFDA),” it said in a BSE filing on Saturday.

The company’s product is the AB rated generic equivalent to Valeant Pharmaceuticals North America LLC’s Wellbutrin tablets. It is used for the treatment of major depressive disorder and prevention of seasonal affective order in adults, the filing said.

As per IMS MAT December 2016 data, Wellbutrin tablets have sales of $755 million in the American market.