East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300mg and 400mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg. to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug SEROQUEL XR®

Quetiapine Fumarate ER tablets are indicated for the treatment of schizophrenia, manic or mixed episodes associated with bipolar I disorder and as an adjunct therapy to antidepressants for the treatment of major depressive disorder (MDD).

The product has an estimated market size of $816M for the twelve months ending October 2017 according to IMS*.

Quetiapine Fumarate ER tablets 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg. represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 285 final approvals, including 36 tentative approvals, and 16 approved products from Aurolife. There are 116 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT October 2017