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FDA nod to Lupin for generic Seroquel tablets

Staff reporter, New Delhi
19/05/2017   0 Comments

The United States Food and Drug Administration (FDA) has given its approval to Pharma Major Lupin for its Quetiapine Fumarate Extended-Release Tablets to market a generic version of AstraZeneca Pharmaceuticals LP’s Seroquel XR Tablets.

Lupin’s Quetiapine Fumarate Extended-Release Tablets available in 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. 

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.
 

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