Impax Laboratories has confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.
The Company received approval on the 250mg tablets in May 2009. Abbott Laboratories markets Depakote® ER for the treatment of epilepsy and bipolar disorders.
The Company expects to launch both the 250mg and 500mg tablets immediately, through Global Pharmaceuticals, Impax’s generic division.
According to Wolters Kluwer Health, U.S. sales of Depakote® ER 250mg and 500mg tablets were approximately $93 million and $633 million, respectively, for the 12 months ended June 30, 2009.
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