Drug developer Impax Laboratories, Inc. (IPXL) announced Wednesday that the U.S. Food and Drug Administration or FDA has given final approval of Impax's Abbreviated New Drug Application or ANDA for generic version of the anticonvulsant drug Depakote 500mg Extended-release Tablets.
The company received approval on the 250 mg tablets in May this year. Abbott Laboratories markets the divalproex-containing drug for the treatment of epilepsy and bipolar disorders.
Impax revealed that it is looking forward to launching both versions of the tablets immediately, through its generic division, Global Pharmaceuticals.
According to the medical publisher Wolters Kluwer Health, U.S. sales of Depakote ER 250 mg for the year ended June 30, 2009 were $93 million and sales of 500mg tablets were around $633 million.
IPXL is currently trading at $7.43, down $0.05 or 0.67%, on the NASDAQ.
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