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news.Mylan, a diversified generic and pharmaceutical company, has announced that its subsidiary Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for divalproex Sodium extended-release tablets, 250mg and 500mg.
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Mylan has been awarded 180 days of marketing exclusivity for the 500mg strength, which it will begin to ship February 2, 2009. Mylan was the first company to file a substantially complete abbreviated new drug application containing a Paragraph IV certification for the 500mg strength.
Divalproex Sodium extended-release (Divalproex ER) tablets are the generic version of Abbott Laboratories’s Depakote ER.