Teva Pharmaceutical Industries has announced that the FDA has granted tentative approval for the company's abbreviated new drug application to market its generic version of AstraZeneca's antipsychotic agent Seroquel tablets, equivalent to 25mg base, 50mg base, 100mg base, 150mg base, 200mg base, 300mg base and 400mg base.
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Final approval of this product is expected upon resolution of patent litigation.
According to Teva, the brand product had annual sales of approximately $3.8 billion in the US for the 12 months that ended September 30, 2008, based on IMS sales data.
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