Our News Bureau – Mumbai
Sun Pharmaceutical Industries announced that US FDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) for generic version of Seroquel, quetiapine fumarate tablets, in multiple strengths.
These generic quetiapine fumarate tablets, 25 mg (base), 50 mg (base), 100 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base) are therapeutic equivalents of AstraZeneca LP’s Seroquel tablets of similar strengths. Quetiapine fumarate tablets have annual sale of approximately $4.5 billion in the US.
Quetiapine fumarate tablets are indicated for the treatment of schizophrenia and acute treatment of manic episodes associated with bipolar disorder, both as monotherapy and as an adjunct to lithium or divalproex. It is also indicated for acute treatment of depressive episodes associated with bipolar disorder as well as maintenance treatment of bipolar disorder as an adjunct to lithium or divalproex.
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