Impax' generic Depakote gets final FDA clearance
US firm Impax Laboratories has confirmed that the Food and Drug Administration has granted final approval of the company's Abbreviated New Drug Application for a generic version of Depakote (divalproex ER) 250mg extended-release tablets. The firm also received tentative clearance on the 500mg tablets and expects to receive final approval on August 3, upon expiration of the 180-day exclusivity period. Abbott Laboratories markets Depakote ER for the treatment of epilepsy and bipolar disorders.
Impax expects to launch both the 250mg and 500mg tablets on August 3 through Global Pharmaceuticals, its generic division. According to Wolters Kluwer Health, US sales of Depakote ER 250mg and 500mg tablets were around $115.0 million and $796.0 million, respectively, for the 12 months ended March 2009.
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