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news.Biovail, a specialty pharmaceutical company, has announced that the FDA has accepted the company's abbreviated new drug application for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets.
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The quetiapine fumarate extended-release tablets are sold under the brand name Seroquel XR by AstraZeneca Pharmaceuticals. This represents Biovail’s third successful abbreviated new drug application (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.