Breckenridge announced that the Food and Drug Administration (FDA) has approved Quetiapine Fumarate Tablets, the generic version of AstraZeneca’s Seroquel.

Seroquel is an atypical antipsychotic indicated for the treatment of schizophrenia; acute mania in bipolar I disorder; as adjunct to lithium or valproate for acute mania and maintenance treatment; and for depressive episodes associated with bipolar disorder. It has been proposed that the efficacy of Seroquel in schizophrenia and its mood stabilizing properties in bipolar depression and mania are mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism.

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Quetiapine Fumarate Tablets will be available in 25mg, 50mg, 100mg, 200mg, 300mg, and 400mg strengths. Plans for its launch are still being finalized.

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