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news.Impax Laboratories, a technology-based specialty pharmaceutical company, has confirmed that the FDA has granted final approval of the company's abbreviated new drug application for generic version of Depakote 250mg extended-release tablets.
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The company also received tentative approval on the 500mg tablets and expects to receive final approval on August 3, 2009, upon expiration of the 180-day exclusivity period.
Abbott Laboratories markets Depakote ER for the treatment of epilepsy and bipolar disorders.
The company expects to launch both the 250mg and 500mg tablets on August 3, 2009, through Global Pharmaceuticals, Impax’s generic division.