Lupin gets USFDA nod for Quetinpine Furmarate tablet

28 Mar 2012 Evaluate

Lupin, country’s pharma major has received final approval for its Quetinpine Furmarate tablet 25mg, 50mg, 100mg, 200mg, 300mg and 400 mg strengths from the US Food and Drugs Administration (FDA). Quetinpine Furmarate tablet is AB rated generic equivalent of AsrtraZenca’s Seroquel tablet (25, 50, 100, 200, 300 and 400mg).

The company has already started shipping the product. Quetinpine is a psychotropic agent, indicated for treatment of schizophrenia and acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy. It is also indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder and for the maintenance treatment of bipolar disorder as an adjunct to lithium or divalprocx. As per IMS Health, December 2011, AsrtraZenca’s Seroquel had sales of $4.6 billion.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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