ROCKVILLE, Md. The Food and Drug Administration has approved two generic versions of Abbott’s epilepsy and bipolar disorder drug Depakote ER, agency records show.
The FDA gave tenative approval to Zydus Pharmaceuticals' divalproex sodium tablets in the 500 mg strength on Feb. 27. It also gave approval to Anchen Pharmaceuticals 250 mg tablets in the 250 mg strength, with an approval date of March 26.
The branded version of the drug had sales of $803 million during the 12 months ending in March 2008, according to IMs Health data.