Biovail says FDA accepts ANDA for Quetiapine XR - Quick Facts

Biovail Corp. (BVF, BVF.TO) announced that FDA has accepted its abbreviated new drug application or ANDA for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets or Quetiapine XR.

AstraZeneca Pharmaceuticals LP (AZN) has been marketing the drug under the name Seroquel XR and has generated U.S. revenue of approx. $166 million in the twelve-month period ended September 30, 2008. Seroquel XR is an antipsychotic agent indicated for the treatment of schizophrenia and bipolar disorder.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com