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news.Mylan Pharmaceuticals, a subsidiary of Mylan Laboratories, has received tentative approval from the FDA for its generic version of Abbott's Depakote extended release tablets.
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Mylan has received the tentative approval for the drug in 250mg and 500mg strengths. Depakote ER is approved in the US for the treatment of bipolar disorder, epilepsy, and the prevention of migraine in adults.
Divalproex sodium ER tablets are the generic version of the drug, which had US sales of approximately $698 million for the same strengths for the 12-month period ending December 31, 2006, according to IMS Health.