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Aurobindo Pharma CNS drug receives FDA nod

Aurobindo Pharma has received marketing and manufacturing approval from the US Food and Drug Administration (FDA) for Divalproex Sodium delayed - release tablets USP 125mg, 250mg and 500mg.

Depakote delayed-release tablets falls under the central nervous system (CNS) therapeutic category as a treatment for the manic episodes associated with bipolar disorder.

They are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures and for prophylaxis of migraine headaches.

Divalproex Sodium delayed – release tablets USP 125mg, 250mg and 500mg are the generic version Abbott Laboratories’ Depakote delayed-release tablets USP 125mg, 250mg and 500mg.