Our News Bureau – Mumbai
Lupin has received final approval for its quetiapine fumarate tablets 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg strengths from the US Food and Drug Administration (FDA). Quetiapine Fumarate Tablets is AB rated generic equivalent of AstraZeneca’s Seroquel tablets (25, 50, 100, 200, 300 & 400 mg). The company has launched and commenced shipping of the product in the US, UK and Germany market.
Quetiapine is a psychotropic agent, indicated for treatment of schizophrenia and acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. It is also indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder and for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.
Lupin has issued a statement mentioning, “We expect substantial price erosion due to competition and we are confident that we will garner healthy market share of the product given our track record in the US and European Generics market.”