Biovail Corporation announced that the United States Food and Drug Administration (FDA) has accepted the company's abbreviated new drug application (ANDA) for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets (sold under the brand name Seroquel XR by AstraZeneca Pharmaceuticals LP). This represents 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 US revenues of approximately $166 million in the twelve-month period ended September 30, 2008.
Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products.