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Sun Pharma and Lupin receive US FDA approval for divalproex tablets

This article was originally published in Scrip

Executive Summary

Sun Pharmaceutical Industriesand Lupin's US subsidiary have received final approval from the US FDAfor their respective ANDAs for divalproex sodium delayed-release tablets 125mg, 250mg and 500mg, generic versions of Abbott Laboratories' Depakote tablets. Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches. Both companies expect their products to be on the market shortly. The three strengths of Depakote delayed release tablets reported annual sales of about $750 million in the US.



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