Final appro for Mylan's generic Depakote
US generics major Mylan Pharmaceuticals has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for divalproex sodium extended-release tablets, 250mg and 500mg, a copy version of Abbott Laboratories' Depakote, which had sales of around $900.0 million in the 12 months to September 2008,
Mylan has been awarded 180 days of marketing exclusivity for the 500mg strength, which it will begin to ship February 2. It was the first company to file a substantially complete ANDA containing a Paragraph IV certification for the 500mg strength. Mylan is shipping the 250mg strength immediately.
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