Lupin receives USFDA approval for generic Seroquel XR Tablets

19 May 2017 Evaluate

Lupin 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 (USFDA) to market a generic version of AstraZeneca Pharmaceuticals LP’s Seroquel XR Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. Seroquel XR Extended-Release Tablets had US sales of $1.27 billion, according to IMS MAT March 2017.

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 disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.


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