The USFDA has accepted the Bioavail’s ANDA for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate ER tablets (sold under the brand name Seroquel XR by AstraZeneca Pharmaceuticals LP). This is Biovail's third successful ANDA filing in 2008. Seroquel XR is an atypical antipsychotic agent indicated for the treatment of schizophrenia and bipolar disorder. The product is available in 150mg, 200mg, 300mg and 400mg strengths. According to IMS Health, Seroquel XR generated U.S. revenues of approximately $166 million in the twelve-month period ended September 30, 2008.
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