Aurobindo Pharma receives final approval for Divalproex Sodium Delayed-Release Tablets

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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration 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 and will be launched soon.

Aurobindo now has a total of 135 ANDA approvals (104 Final approvals and 31 Tentative approvals) from USFDA

 

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