Biovail files ANDA for quetiapine
Canada's Biovail Corp says that the US Food and Drug Administration has accepted its Abbreviated New Drug Application for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets (sold under the brand name Seroquel XR by Anglo-Swedish drug major AstraZeneca). This represents Biovail's third successful ANDA filing in 2008, the firm claims.
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 about $166.0 million in the 12-month period ended September 30.
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