Lupin Limited receives FDA approval for generic Seroquel XR Tablets

Mumbai: Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg from the United States Food and Drug Administration (FDA) to market a generic version of AstraZeneca Pharmaceuticals LP’s Seroquel XR® Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Lupin’s Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg are the AB rated generic equivalent of AstraZeneca Pharmaceuticals LP’s Seroquel XR® Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

It is indicated for the treatment of schizophrenia; acute manic or mixed episodes in bipolar I disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Seroquel XR® Extended-Release Tablets had US sales of USD 1.27 billion (IMS MAT March 2017).