Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Divalproex Sodium Delayed- Release Tablets USP 125mg, 250mg and 500mg

Divalproex sodium delayed-release tablets USP 125mg, 250mg and 500mg are the generic equivalent of Abbott Laboratories’ Depakote Delayed-Release Tablets USP 125mg, 250mg and 500mg. Divalproex sodium delayed-release tablets falls under the Neurological (CNS) therapeutic category and are indicated for the treatment of the manic episodes associated with bipolar disorder; 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. The product has a market size of approximately US$ 144 Million for the twelve months ending September 2010 according to IMS. The company in a statement said that it will launch the products shortly.

Aurobindo now has a total of 135 ANDA approvals, including104 final approvals and 31 tentative approvals, from US FDA.