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16 April, 2024 18:17 IST
Lupin receives USFDA nod for generic Seroquel XR tablets
Source: IRIS | 19 May, 2017, 08.20AM
Rating: NAN / 5 stars.
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Pharma Major Lupin announced today that it has received final approval for its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg from the United States Food and Drug Administration (FDA) to market a generic version of AstraZeneca Pharmaceuticals LP's Seroquel XR Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Lupin's Quetiapine Fumarate Extended-Release Tablets, 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 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

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.

Seroquel XR Extended-Release Tablets had US sales of USD 1.27 billion (IMS MAT March 2017).

Shares of the company gained Rs 7.85, or 0.61%, to trade at  Rs 1,304.90.  The total volume of shares traded  was  67,273 at the BSE (4.01 p.m., Thursday).

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